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Standardized Mite Dermatophagoides farinae 30000 [AU]/mL Concentrate, 30 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Standardized Insect Allergenic Extract class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 Inactive Ingredients / Excipients
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
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UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
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| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Standardized Mite Dermatophagoides farinae 30000 [AU]/mLthis 22840-0038-08 | Greer | 30 ml | — | — | FDA listed | — |
| Standardized Mite, Dermatophagoides farinae, Scratch or Bulk, 30000 AU per mL 30000 [AU]/mL 65044-6720-01 | Jubilant | 5 ml | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 22840-0038-06 | 10 mL in 1 VIAL, MULTI-DOSE (22840-0038-6) | 2010-02-03 | Active |
| 22840-0038-08 You're viewing this | 30 mL in 1 VIAL, MULTI-DOSE (22840-0038-8) | 2010-02-03 | Active |
| 22840-0038-09 | 50 mL in 1 VIAL, MULTI-DOSE (22840-0038-9) | 2010-02-03 | Active |
You're viewing one of 3 pack sizes for this product.
Pack size FAQ
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ANAPHYLAXIS Do not inject intravenously. (2.2) Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death. (5.1) This allergenic product is intended for use only by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist.
(5.1) The initial dose must be based on skin test. (2.1) Observe patients in the office for at least 30 minutes following treatment. Emergency measures and personnel trained in their use must be available immediately in the event of life threatening reaction.
(5.1) Immunotherapy may not be suitable for patients with medical conditions that reduce their ability to survive a systemic reaction, including significant cardiovascular and/or pulmonary diseases. Patients who are receiving beta blockers may be unresponsive to the usual doses of epinephrine used to treat systemic reactions, including anaphylaxis. (5.2) WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning.
Do not inject intravenously (2.2) Allergenic extracts may cause severe life-threatening systemic reactions, including the rare occurrence of anaphylaxis or death (5.1) Intended for use only by experts experienced in administering allergic extracts and trained to provide emergency treatment (5.1) Initial dose must be based on skin test (2.1) Observe patients in the office for at least 30 minutes following treatment. Emergency measures and personnel trained in their use must be available immediately in the event of life threatening reaction (5.1) Immunotherapy may not be suitable for patients with medical conditions that reduce their ability to survive a systemic reaction (5)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) Extracts are allergenic extracts indicated for: skin test diagnosis of mite allergy treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis. For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae ( D. farinae ) or Dermatophagoides pteronyssinus ( D. pteronyssinus ) based on their clinical history, allergen exposure history, and skin test reactivity.
Greer Standardized Mite Extracts are allergenic extracts indicated for: Diagnosis of skin test reactivity to dust mite allergen (1) Treatment of mite-induced allergic asthma, rhinitis and conjunctivitis in patients that show hypersensitivity to dust mites based on clinical history, allergen exposure history, and skin test reactivity (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Do not inject intravenously. Greer Standardized Mite extracts are diluted with sterile diluent for allergenic extracts when used for intradermal testing or subcutaneous immunotherapy. Dosages vary by mode of administration, and by individual response and tolerance.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Greer Standardized Mite Extracts should be a light brown solution that is free of particulate matter. If particulate matter is observed then the solution should be discarded.
2.1Diagnostic Testing For diagnosis of a patient with a suspected allergy to either species of dust mite ( D. farinae or D. pteronyssinus ), diagnostic skin testing should include the standardized mite mixture or the single-species mite extracts. If a skin test with the standardized mite mixture elicits a positive reaction, then the single-species mite extracts can be used to determine the degree of sensitivity to each, and to guide in the selection of extracts and their concentration for immunotherapy, if indicated.
A positive skin test reaction to any allergen must be interpreted in light of the patient's history of symptoms, the time of year, and known exposure to environmental allergens. 2.1.1 Percutaneous Skin Testing For percutaneous (scratch, prick, or puncture) testing, use 10,000 Allergy Units/mL Greer Standardized Mite Extract stock concentrate in dropper vials. If patient is suspected of having exquisite sensitivity, such as anaphylaxis, to certain foods and drugs, initiate percutaneous testing with several serial 10-fold dilutions of the usual test concentration.
For scratch tests, scarify the skin, and then apply one drop of the extract to the scratch. For prick tests, place one drop of extract on the skin and pierce through the drop into the skin with a slight lifting motion. For puncture tests, place one drop of extract on the skin and pierce through the drop perpendicular to the skin.
When using percutaneous test devices, follow the directions provided with the test devices. Include a positive control to detect false negative responses to skin testing, which may occur if serum levels of antihistamines remain from prior medication administration [see Drug Interactions (7.2)]. A glycerinated histamine phosphate diluted to 10 mg/mL (6 mg/mL histamine base) may be used as the positive control.
Include a negative control to detect false positive responses, which can occur when the patient has a non-specific reaction to the diluent. A 50% glycerosaline solution may be used as the negative control. Read skin tests 15-20 minutes after exposure.
Record the induration (wheal) and erythema (flare) response by noting the longest diameter of each, or by the sum of the longest erythema diameter and the mid-point orthogonal diameters of erythema (ΣE). Percutaneous testing devices often have their own grading systems, as these devices may cause different degrees of trauma to the skin and deliver different volumes of allergenic extract. Follow grading instructions for the device used.
2.1.2Intradermal Skin Testing Intradermal tests are commonly used when the reaction to percutaneous testing is negative or equivocal but the patient has a strong clinical history of symptoms triggered by exposure to a specific allergen. Because immediate systemic reactions are more common with intradermal testing, prescreening with percutaneous testing is a practical safety measure. 1 Dilute the stock concentrate with sterile diluent.
Use saline with human serum albumin (HSA), buffered saline, or saline. If prescreening is not done, or if patients are expected to be high risk, precautions should be observed since some patients have experienced anaphylaxis and death. Patients who do not react to percutaneous skin testing should be tested intradermally at a starting dose of 0.02 to 0.05 mL of a 50 Allergy Units/mL extract dilution…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline. For intradermal testing extracts may be diluted in normal saline, buffered saline, or albumin saline. Greer Standardized Mite Extract D. farinae and Greer Standardized Mite Extract D. pteronyssinus are supplied as stock concentrates containing 10,000 Allergy Units/mL and Greer Standardized Mite Extract mixture ( D. farinae and D. pteronyssinus ) is supplied as a stock mixture concentrate containing 5,000 Allergy Units/mL of each species for use in percutaneous skin testing.
Greer Standardized Mite Extract D. farinae and Greer Standardized Mite Extract D. pteronyssinus are supplied as stock concentrates containing 5,000, 10,000, or 30,000 Allergy Units/mL. Greer Standardized Mite Extract mixture ( D. farinae and D. pteronyssinus ) is supplied as a stock mixture concentrate containing 5,000 and 15,000 Allergy Units/mL of each species for use in intradermal testing and immunotherapy. For percutaneous testing, Greer Standardized Mite Extract stock concentrates containing 10,000 Allergy Units/mL of Dermatophagoides farinae ( D. farinae ), Dermatophagoides pteronyssinus ( D. pteronyssinus ), or both D. farinae and D. pteronyssinus are supplied in 5 mL dropper vials (3) For intradermal testing or immunotherapy, Greer Standardized Mite Extracts stock concentrates containing a total of 5,000, 10,000 or 30,000 Allergy Units/mL of D. farinae , D. pteronyssinus , or a mixture of D. farinae and D. pteronyssinus are supplied in 10, 30 and 50 mL multiple-dose vials (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS
5.1Serious Systemic Reactions All concentrates of Greer Standardized Mite Extracts have the ability during skin testing and immunotherapy to elicit serious systemic reactions including anaphylactic shock and death [see Adverse Reactions (6)]. A review of the literature indicates that the incidence of near-fatal reactions to immunotherapy, defined as severe respiratory compromise, hypotension, or both, and requiring emergency treatment with epinephrine, has been estimated as 5.4 events per million injections in a 10-year retrospective survey of allergists.
3 Fatalities from immunotherapy injections have been estimated to occur at a rate of approximately one death per 2.0 to 2.8 million injections in 4-, 10- and 12-year retrospective surveys of allergists. 4-6 Because of the danger of serious reactions, caution is required in testing and treating high risk patients and those with medical conditions that reduce their ability to survive a serious systemic adverse event. High-risk patients are defined as those patients: with labile or steroid-dependent asthma, particularly in those suffering an exacerbation of their symptoms at the time of extract administration; with extreme sensitivity to a particular allergen(s); who are currently using beta blockers; who are receiving an accelerated immunotherapy build-up schedule (e.g., rush immunotherapy); who are being changed from one allergenic extract to another; who are receiving high doses of allergenic extracts.
High risk patients have had fatal reactions. In addition, patients not high-risk but on beta blockers have had fatal reactions because beta blockers interfere with beta adrenergics such as epinephrine used in treatment or anaphylaxis. Patients should be kept under observation for a minimum of 30 minutes after receiving allergenic extracts so that any adverse reaction can be observed and properly handled.
2 Medications to treat systemic reactions, as well as emergency equipment should be available for immediate use. Extracts must only be administered by persons who are aware of the risk of systemic reactions, including anaphylaxis; are capable of handling such reactions; and have the necessary drugs and equipment on hand to do so.
5.2Patients on Beta Blockers Patients receiving beta blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Inhalant allergy immunotherapy should be approached with caution in patients taking beta blockers. The risks of anaphylaxis in these patients should be carefully weighed against the benefits of immunotherapy [see Drug Interactions (7.1)].
5.3Autoimmune Disease Immunotherapy should be given cautiously to patients with other immunologic diseases and only if the risk from exposure to the allergen is greater than the risk of exacerbating the underlying disorder. 2 All concentrates of Greer Standardized Mite Extracts can cause serious systemic reactions of varying degrees of severity, including anaphylactic shock and death, particularly in patients: With labile or steroid-dependent asthma (5.1) With extreme sensitivity to allergen(s) (5.1) Who are currently using beta blockers (5.2) Who are on an accelerated immunotherapy build-up schedule (5.1) Who are being changed from one allergenic extract to another (5.1) Who are receiving high doses of allergen extracts (5.1)
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Systemic reactions consist primarily of allergic symptoms, such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. Additional symptoms that are not usually associated with allergy also may occur, such as nausea, emesis, abdominal cramps, and diarrhea. Serious reactions may cause shock, loss of consciousness, and even death.
Based on published studies, 7,8 systemic reactions occur in less than 1% of patients receiving conventional immunotherapy to greater than 36% in some studies of patients receiving rush immunotherapy. Local reactions at the injections site are the most commonly occurring reactions (e.g., erythema, itching, swelling, tenderness, pain). Although most adverse systemic reactions occur within 30 minutes of injection (some within minutes of extract exposure), such reactions also can occur up to six hours after skin tests or immunotherapy [see Dosage and Administration (2.2)].
9 Systemic reactions may be fatal or near fatal (6) Systemic reactions (e.g. generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension) occur in 4-7% of patients The most common reactions are local reactions at the injection site (e.g., erythema, itching, swelling, tenderness, pain), occuring in 26% to 82% of patients (6) To report SUSPECTED ADVERSE REACTIONS, contact Greer Laboratories, Inc., at 1-855-274-1322 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Beta Adrenergic Drugs Patients receiving beta blocker drugs may not be responsive to beta adrenergic drugs used to treat anaphylaxis 10 , and may wish to temporarily postpone treatment day of skin testing. All such decisions should be made in consultation with the physician [see Warnings and Precautions (5.2)].
7.2Antihistamines 1 Skin testing with allergenic extracts should not be performed within 2-3 days of first-generation H 1 -histamine receptor blockers (e.g., clemastine, diphenhydramine) and within 3 to 10 days of second-generation antihistamines (e.g., loratadine, terfenadine), except for astemizole, which requires an interval of 30-60 days between allergenic extract exposure and use. These products suppress histamine skin test reactions and could mask a positive response.
7.3Topical Corticosteroids and Topical Anesthetics 1 Topical corticosteroids may suppress skin reactivity and should be discontinued at the skin test site for at least 2-3 weeks before skin testing. Topical local anesthetics may suppress flare responses and should be avoided at skin test sites.
7.4Tricyclic Antidepressants 1 Tricyclic antidepressants can have potent antihistamine effects and will affect skin testing. Since use of tricyclics may alter skin test results, dosing for both skin testing and immunotherapy should be done with caution. If tricyclic medication has been recently discontinued, allow 7-14 days prior to skin testing to obviate the antihistamine effect.
The risk of anaphylaxis in these patients should be carefully weighed against the risks and benefits of stopping tricyclics.
7.5Other Drugs The suppressive action of other drugs should be considered and emphasizes the need for a histamine positive-control test. Patients who are receiving beta agonists may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis (7.1) Patients should discontinue medications known to suppress the histamine response prior to skin testing including: antihistamines (7.2), tricyclics (7.4), and topical corticosteroids and topical anesthetics (7.3)
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with Greer Standardized Mite Extracts. It is also not known whether Greer Standardized Mite Extracts can cause fetal harm when administered to a pregnant woman or whether they can affect reproduction capacity. Standardized Mite Extracts should be given to a pregnant woman only if clearly needed.
Studies have not been performed in animals to determine whether extracts affect fertility in males or females, have teratogenic potential, or have other adverse affects on the fetus. Exercise caution in testing or treating pregnant females because a systemic reaction may cause maternal cardiovascular compromise leading to fetal distress with sequelae.
8.3Nursing Mothers It is not known whether allergenic extracts or their antigens are excreted in human milk. Because many drugs are excreted in human milk, exercise caution when extracts are administered to a nursing woman.
8.4Pediatric Use No studies have systematically examined differences in response to immunotherapy among child and adult patients. Children appear to tolerate injections of allergenic extracts very well. 2 Very young children (under age 5) can have difficulty cooperating with an immunotherapy program and for this reason, the physician should consider the benefits and risks of immunotherapy and indiviualize treatment in patients under the age of 5 years [see Warnings and Precautions (5)].
8.5Geriatric Use Clinical studies of Greer Standardized Mite Extract did not include sufficent numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experiences has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of concomitant disease or other drug therapy including beta blockers.
2 Pregnancy: No human or animal data. Use only if clearly needed (8.1) Autoimmune Disease: Immunotherapy may exacerbate the autoimmune disease. Use only if clearly needed (5.3) See 17 for PATIENT COUNSELING INFORMATION.
Revised: 1/2013
🆘 Overdosage ▾
10 OVERDOSAGE For all allergenic extracts the therapeutic dose varies per indiviual. If a dose exceeds the window for a particular patient this may be considered an overdose and the patient may experience anaphylaxis. Systemic reactions are uncommon after injection, but if the patient receives more extract than can be tolerated at that particular time, and begins to experience immediate hypersensitivity anaphylaxis, institute emergency treatment by trained personnel.
Overdosage may occur because of an error in the volume of extract or incorrect diluents injected. An overdose may also occur when, in addition to immunotherapy, the patient is exposed concomitantly to similar environmental allergens. In the event of a systemic reaction, the preparation of allergen and dosage schedule should be carefully reviewed.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY Dust mites belonging to the genus Dermatophagoides are indoor allergens found in humid geographic locations worldwide. D. farinae and D. pteronyssinus occur widely with most homes in the United States coinhabited by both species. 11
12.1Mechanism of Action The complete mechanisms of allergen immunotherapy are not clear and remain the subject of investigation. The allergic reaction is dependent on the presence of allergen-specific immunoglobulin E (IgE) antibodies that are bound to specific receptors on mast cells and basophils. The presence of IgE antibodies sensitizes these cells, and upon interaction with the appropriate allergens, histamine and other mediators are released which produce local or systemic responses in sensitive individuals, and characteristic symptoms of atopic diseases, such as allergic rhinitis and allergic asthma.
Changes in serum antibody and T-lymphocyte responses resulting from immunotherapy have been demonstrated, and these changes often correlate closely with clinical (symptom) improvements. Specific mechanisms may vary depending on the nature of the allergic disease, the allergenic specificities of patients and populations, extract formulations, route of administration, dose and duration of treatment. 2 Subcutaneous administration of allergenic extracts is known to elicit numerous immunological changes that are both time and dose-dependent.
Many of these changes appear to be related to (or a precursor to) improvements in symptoms and other clinical parameters, as noted above. Specific changes found after immunotherapy with dust mite extracts include significant increases in mite-specific IgG4 antibodies 12 , interleukin-10-positive T cells, and several T-cell receptors, and significant decreases in serum nitric oxide, eosinophil catonic protein, interleukin-4-positive T cells and IgE-mediated basophil histamine release. 13
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Mite extracts in 50% Glycero-Coca solution are supplied as follows: D. farinae : NDC 22840-0033 5,000 Allergy Units/mL, 10, 30, and 50 mL vials D. farinae : NDC 22840-0034 10,000 Allergy Units/mL, 5 mL percutaneous test vial D. farinae : NDC 22840-0034 10,000 Allergy Units/mL, 10, 30, and 50 mL vials D. pteronyssinus : NDC 22840-0035 5,000 Allergy Units/mL, 10, 30, and 50 mL vials D. pteronyssinus : NDC 22840-0036 10,000 Allergy Units/mL, 5 mL percutaneous test vial D. pteronyssinus : NDC 22840-0036 10,000 Allergy Units/mL, 10, 30, and 50 mL vials D. farinae / D. pteronyssinus mixture: NDC 22840-0037 5,000 Allergy Units/mL each species, 5 mL percutaneous test vial D. farinae / D. pteronyssinus mixture: NDC 22840-0037 5,000 Allergy Units/mL each species, 10, 30, and 50 mL vials D. farinae : NDC 22840-0038 30,000 Allergy Units/mL, 10, 30, and 50 mL vials D. pteronyssinus : NDC 22840-0039 30,000 Allergy Units/mL, 10, 30, and 50 mL vials D. farinae / D. pteronyssinus mixture: NDC 22840-0040 15,000 Allergy Units/mL each species, 10, 30, and 50 mL vials
16.2Storage and Handling Store dust mite extract at 2 to 8°C (36 to 46°F). Keep dust mite extract at 2 to 8°C (36 to 46°F) during office use. Dilutions of concentrated extract result in a glycerin content of less than 50% which results in reduced stability of the extracts.
1:100 dilutions should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known mite allergic individual.
📋 Description ▾
11 DESCRIPTION Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus ), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.
For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies.
The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL.
The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.