Hepanostika Anti-HAV MidroElisa System

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

Full name

Hepanostika(Tm) Anti-Hav Midroelisa System

Generic Name

Hepatitis a test (antibody and igm antibody)

PMA Number

P830018 ↗

FDA Product Code

LOL

Device Class

Class II

Regulation

21 CFR Part 866.3310

Advisory Committee

Microbiology

FDA Decision

APRL

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See all devices from Organon Teknika Corp. →

• What is the primary purpose of the HEPANOSTIKA™ ANTI-HAV MIDROELISA SYSTEM in a clinical setting?

  The HEPANOSTIKA™ ANTI-HAV MIDROELISA SYSTEM is designed to detect both anti-HAV antibodies and IgM antibodies against the Hepatitis A virus in human serum or plasma. This helps clinicians diagnose Hepatitis A infections by identifying whether a patient has been exposed to the virus or is in the acute phase of infection, based on the presence of these markers.

• Is this device intended for single-use, or can it be reused after initial use?

  The HEPANOSTIKA™ ANTI-HAV MIDROELISA SYSTEM is explicitly supplied as a single-use kit per the manufacturer’s specifications. This ensures accuracy and sterility for each test, as reuse could compromise results or introduce contamination risks.

• How should the HEPANOSTIKA™ ANTI-HAV MIDROELISA SYSTEM be stored, and what are the key handling considerations?

  Like most immunoassay kits, this system requires adherence to standard laboratory storage protocols to maintain sterility and performance. The manufacturer does not specify exact storage conditions in the provided data, but typical practices include storing at 2–8°C (36–46°F) in a dry environment, away from direct light, until use. Always follow the included instructions for handling to avoid degradation of reagents.

• What regulatory pathway does this device follow, and how does that affect its use in the U.S.?

  The HEPANOSTIKA™ ANTI-HAV MIDROELISA SYSTEM is regulated under FDA Premarket Approval (PMA) and classified as a Class II medical device under 21 CFR 866.3310. This means it underwent rigorous review by the FDA’s Microbiology Devices Advisory Committee (MI) before approval, ensuring its safety and effectiveness for detecting Hepatitis A antibodies in clinical settings. Clinicians and labs can rely on its regulatory clearance for diagnostic use in the U.S.