Hepanostika(Tm) Hbeag/Anti Hbe Microelisa(Tm) Syst

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

Generic Name

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

PMA Number

P840070 ↗

FDA Product Code

LOM

Device Class

Class II

Regulation

21 CFR Part 866.3172

Advisory Committee

Microbiology

FDA Decision

APRL

• Fibrinostika Tdp Microelisa System

  Class II

  FDA 510(k) K915698 Active Cleared 5 Aug 1992

• Nephross I.Q. Andante

  Class II

  FDA 510(k) K874549 Active Cleared 29 Jan 1988

• Mda Protein Assay

  Class II

  FDA 510(k) K925617 Active Cleared 27 Jan 1994

• Bsm 2000 Dialysis Machine

  Class II

  FDA 510(k) K840062 Active Cleared 22 Mar 1984

• Bact/Alert Culture Bottles

  Class I

  FDA 510(k) K973305 Active Cleared 17 Nov 1997

• Nuclisens Cmv PP67

  Class II

  FDA 510(k) K983762 Active Cleared 15 Sep 1999

See all devices from Organon Teknika Corp. →

• What clinical question does this test help answer in diagnosing Hepatitis B virus infection?

  This test detects Hepatitis B e antigen (HBeAg) and anti-HBe antibodies in human serum or plasma, helping distinguish between acute and chronic phases of Hepatitis B virus infection. By identifying the presence or absence of these markers, clinicians can assess whether a patient is actively replicating the virus (acute/chronic active phase) or transitioning to a less infectious state (chronic inactive phase).

• Is this device intended for reuse, or is it designed for single-use only?

  The HEPANOSTIKA HBEAG/Anti-HBe MicroElisa System is explicitly designed for single-use only. Components are supplied in a non-sterile format for manual preparation, meaning they are not sterilized for reuse and must be discarded after one use to ensure accurate and reliable results.

• How is this test kit supplied, and what preparation is required before use?

  The kit is supplied as a manual in vitro diagnostic system for use in clinical microbiology laboratories. It does not require sterilization before use, but components must be prepared manually according to the included instructions. The system is not pre-assembled or pre-mixed, so users must follow the provided protocol to assemble reagents and perform the MicroElisa assay.

• What regulatory pathway does this device follow, and how does that affect its use?

  This device follows the FDA Premarket Approval (PMA) pathway, with PMA number P840070, under the classification Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen). This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use in diagnosing Hepatitis B infection. Clinicians and laboratories should confirm compliance with the accompanying documentation and storage instructions to maintain validity.