AB-Core K Hepatitis B Core Antigen 125I

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

P850044 ↗

FDA Product Code

LOM

Device Class

Class II

Regulation

21 CFR Part 866.3172

Advisory Committee

Microbiology

FDA Decision

APPR Approved

PMA Supplement

S003 (Normal 180 Day Track)

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See all devices from Sorin Biomedica, Fiat, USA, Inc. →

• What is the AB-CORE K Hepatitis B Core Antigen 125I test used for in clinical practice?

  This test detects antibodies against the hepatitis B core antigen (anti-HBc) to assess past or ongoing exposure to the hepatitis B virus. It helps clinicians evaluate serological markers linked to infection, aiding in diagnostic decision-making for hepatitis B.

• How is the AB-CORE K Hepatitis B Core Antigen 125I test supplied, and what safety precautions must be followed?

  The test is supplied as a single-use kit for in vitro diagnostic use in clinical microbiology laboratories. Due to the presence of radioactive iodine-125 (125I), strict radiation safety protocols must be followed during handling, storage, and disposal to comply with regulatory requirements.

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

  The AB-CORE K Hepatitis B Core Antigen 125I is explicitly designed for single-use only. Reuse is not permitted, particularly due to the radioactive components, which necessitate careful disposal after one use to ensure safety and compliance.

• What regulatory pathway was followed for this device’s approval, and what class does it fall under?

  The device was authorized under the FDA Premarket Approval (PMA) pathway with PMA number P850044. It is classified as a Class II medical device under the LOM (Laboratory and Other Diagnostic Substances) product code, reflecting its specialized diagnostic purpose.

• Are there any specific storage requirements for this test kit beyond standard laboratory conditions?

  While the data does not specify exact storage conditions, the kit contains radioactive materials (125I), so storage must comply with regulatory requirements for radioactive substances—typically including shielding, controlled access, and adherence to local/national radiation safety guidelines. Always refer to the manufacturer’s instructions for precise details.