9EPANOSTIKA(Tm) Anti-Hav Igm

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Hepatitis a test (antibody and igm antibody)

PMA Number

P830017 ↗

FDA Product Code

LOL

Device Class

Class II

Regulation

21 CFR Part 866.3310

Advisory Committee

Microbiology

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

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See all devices from Organon Teknika Corp. →

• What clinical purpose does the 9Epanostika Anti-HAV IgM test serve in diagnosing Hepatitis A infections?

  The 9Epanostika Anti-HAV IgM test detects IgM antibodies to the Hepatitis A virus (HAV) in human serum or plasma, helping clinicians identify acute Hepatitis A infections. IgM antibodies appear early during infection, making this test useful for confirming recent or active cases.

• Is this test kit designed for single-use, or can it be reused after opening?

  The 9Epanostika Anti-HAV IgM is supplied as a single-use reagent kit. It does not require sterilization beyond its original packaging, and the manufacturer does not recommend reuse after opening to maintain accuracy and prevent contamination.

• How is this device regulated, and what does that mean for laboratories using it?

  The 9Epanostika Anti-HAV IgM is regulated under the FDA’s Premarket Approval (PMA) pathway with PMA number P830017 and falls under regulation 866.3310. This means it has undergone rigorous review by the FDA to ensure safety, effectiveness, and proper labeling before clinical use. Laboratories must follow the included instructions for storage, handling, and testing to comply with regulatory requirements.

• What storage and handling precautions should be taken with this test kit?

  While specific storage details are outlined in the accompanying instructions, standard in vitro diagnostic procedures apply. The kit should be stored as directed to preserve its integrity, typically in a clean, dry environment away from extreme temperatures or direct light. Always refer to the manufacturer’s guidelines for exact conditions.