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Monolisa Anti-HBs EIA

FDA PMA

Class II (US FDA PMA)

PMA P050048

by Bio-Rad Laboratories

Identity

Trade Name
MONOLISA ANTI-HBS EIA FDA PMA
Generic Name
Qualitative and Quantitative Hepatitis B Virus Antibody assays FDA PMA

Identifiers

PMA Number
P050048 FDA PMA
FDA Product Code
SEI FDA PMA

Classification

Device Class
Class II FDA PMA
Legislation / Framework
21 CFR Part 866.3173 FDA PMA
Regulation Number
866.3173 FDA PMA
Advisory Committee
Microbiology FDA PMA
FDA Decision
APRL FDA PMA

The Monolisa Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for detecting antibody to hepatitis B surface antigen in human serum, EDTA plasma, or citrated plasma. It is classified as a microbiology device and functions as a serological test to identify anti-HBs antibodies, aiding in the assessment of immunity to hepatitis B virus (HBV). Results assist in determining susceptibility to HBV infection, evaluating vaccination status, and diagnosing HBV-related conditions when etiology is unclear.

This device is supplied as a test kit for 192 tests and requires manual handling in a clinical laboratory setting. It is intended for single-use and does not require sterilization beyond standard laboratory practices. The assay includes a colorimetric readout during protocol execution. Authorized under FDA_PMA (P050048), it adheres to regulatory standards for microbiological assays, with no specific MRI safety or reusable component requirements stated.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MONOLISA Anti-HBs EIA - Bio-Rad, MONOLISA Anti-HBs EIA #25220 | Bio-Rad, PDF MONOLISA TM Anti-HBs EIA 25220 MONOLISA TM Anti-HBs Calibrator Kit 25219, MONOLISA ANTI-HBS EIA (P050048) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA PMA P050048 24 fields · synced Sep 20, 2026