HAVAB-M EIA Diagnostic Kit
by Abbott Laboratories PMA
Active
PMA P790019
Overview
The HAVAB-M EIA Diagnostic Kit is an enzyme immunoassay (EIA) device designed for the qualitative detection of antibodies to Hepatitis A virus (HAV) in human serum or plasma. It identifies both total anti-HAV and IgM anti-HAV, aiding in the diagnosis of Hepatitis A infection and distinguishing between acute and past exposure.
This device is intended for in vitro diagnostic use in clinical microbiology laboratories. Supplied as a single-use kit, it requires no special storage conditions beyond refrigeration (2–8°C) and is not intended for MRI environments. The kit includes all necessary reagents and components for testing, with regulatory clearance granted under FDA PMA (P790019). No sterilisation or reprocessing is required as it is designed for one-time use per sample.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP790019 | Date25 Jun 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
-
- Terminated Z-1036-2007
Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.
Specification
- Full name
- Abbott Havab -M Eia
- Trade Name
- Havab-M Diagnostic Kit
- Generic Name
- Hepatitis a test (antibody and igm antibody)
- PMA Number
- FDA Product Code
- LOL
- Regulation
- 21 CFR Part 866.3310
- Advisory Committee
- Microbiology
- FDA Decision
- APPR Approved
- PMA Supplement
- S002
Other devices from Abbott Laboratories
Questions
What types of samples can the HAVAB-M EIA Diagnostic Kit test for Hepatitis A antibodies, and how does it differentiate between acute and past exposure?
The HAVAB-M EIA Diagnostic Kit is designed to detect both total anti-HAV and IgM anti-HAV antibodies in human serum or plasma. IgM antibodies appear during acute infection, while total antibodies (including IgG) persist after recovery, allowing the test to distinguish between current and past Hepatitis A exposure.
Is the HAVAB-M EIA Diagnostic Kit reusable, or is it intended for single-use per sample?
The kit is explicitly designed for single-use per sample—no sterilization or reprocessing is required. Each kit contains all necessary reagents for one test, ensuring accuracy and compliance with in vitro diagnostic use guidelines.
What storage conditions are required for the HAVAB-M EIA Diagnostic Kit, and does it need special handling?
The kit does not require special storage beyond refrigeration (2–8°C). It is not intended for MRI environments, and no additional handling beyond standard refrigeration is specified.
How was the regulatory approval for this device obtained, and what does the PMA designation mean?
The HAVAB-M EIA received FDA Premarket Approval (PMA) under the designation P790019, which means it underwent a rigorous review process to ensure safety and effectiveness for its intended use in clinical microbiology laboratories. PMA is a formal regulatory pathway for high-risk medical devices.