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Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201)

NAFDAC Reg. No. A3-101017 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201)
NAFDAC number
A3-101017
Active ingredient
Test Kit
Strength
NA
Form
NA
Pack size
1 x 8's
Manufacturer
Not listed
Applicant (holder)
Savante Consulting Limited
Approved
3 Sep 2023
Status
Active View on NAFDAC ↗
Registration valid to
30 Aug 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201) is on the NAFDAC register with an active registration (A3-101017). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201) is used for

From the official U.S. FDA label for test kit, the active ingredient registered with NAFDAC.

Boxed warning: RISK OF SEVERE BRONCHOSPASM Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Bronchial challenge testing with ARIDOL should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. …
What it is used for

ARIDOL is indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. Limitations of Use: ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma. ARIDOL is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. ( 1 ) Limitations of Use: ARIDOL is not a standalone test or a screening test for asthma. …

Possible side effects

The following clinically significant adverse reaction is described elsewhere in the labeling: • Severe Bronchospasm [ see Warnings and Precautions ( 5.1 )]. Most common adverse reactions (rate ≥1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm, Inc. …

Do not use if

ARIDOL is contraindicated in: Patients with known hypersensitivity to mannitol or to the gelatin used to make the capsules Patients with conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers. Some examples include: aortic or cerebral aneurysm, uncontrolled hypertension, recent myocardial infarction or cerebral vascular accident [ see Warnings and Precautions ( 5.2 )]. …

Warnings

& PRECAUTIONS Severe bronchospasm: ARIDOL may cause severe bronchospasm in susceptible patients. Administer by trained professionals under the supervision of a physician. Medications and equipment to treat severe bronchospasm must be present in the testing area. ( 5.1 ) Subjects with co-morbid conditions: Use with caution in patients with conditions that may increase sensitivity to the bronchoconstricting or other potential effects of ARIDOL such as: severe cough, ventilatory impairment, unstable angina, or active upper or lower respiratory tract infection that may worsen with use of a bronchial irritant. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary There are no available human data regarding inhaled mannitol to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, no evidence of structural alterations was observed when mannitol was orally administered to pregnant rats and mice during organogenesis at doses up to approximately 20 and 10 times, respectively, the maximu …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201)

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201)

What is in Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201)?

Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201) contains Test Kit (NA), as na, according to its NAFDAC registration record.

Is Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201) registered with NAFDAC?

Yes. Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201) is listed on the NAFDAC register under registration number A3-101017, and its registration is active as of 5 November 2026.

Has Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201) been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201) in our automatically synced alert list.

How can I check that my pack of Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201) is genuine?

Run a free authenticity scan with the NAFDAC number A3-101017, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Clarus Histoplasma Galactomannan Enzyme Immunoassay (HGM201) used for?

ARIDOL is indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. Limitations of Use: ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma. ARIDOL is a sugar alcohol ind (Summarised from the official U.S. FDA label for test kit. Always follow your doctor or pharmacist.)

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