Imx Havab
by Abbott Laboratories PMA
Active
PMA P780012
Overview
The IMX HAVAB is a diagnostic in vitro device classified as a Hepatitis A Test (Antibody and IgM Antibody), designed to detect antibodies and IgM antibodies to the Hepatitis A virus in human serum or plasma. It is intended for use in microbiology laboratories to aid in the diagnosis of Hepatitis A infection by identifying immune responses to the virus.
The IMX HAVAB is supplied as a reagent kit for use with the IMx system, a fully automated immunoassay analyzer. It is intended for single-use and requires no special storage conditions beyond those specified in the accompanying instructions. The device holds an FDA Premarket Approval (PMA) under PMA number P780012, with regulatory compliance under 21 CFR 866.3310. Authorized use is restricted to qualified laboratories and healthcare settings equipped with the IMx system.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP780012 | Date25 Jun 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
-
- Terminated Z-1039-2007
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
- Trade Name
- Havab
- Generic Name
- Hepatitis a test (antibody and igm antibody)
- PMA Number
- FDA Product Code
- LOL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3310
- Advisory Committee
- Microbiology
- FDA Decision
- APPR Approved
- PMA Supplement
- S004
Other devices from Abbott Laboratories
Questions
What is the primary purpose of the IMX HAVAB device in a clinical setting?
The IMX HAVAB is designed to detect antibodies and IgM antibodies to the Hepatitis A virus in human serum or plasma. This helps microbiology laboratories identify immune responses to Hepatitis A infection, aiding in the diagnosis of the disease.
How is the IMX HAVAB supplied and what system does it require for use?
The IMX HAVAB is supplied as a reagent kit specifically for use with the IMx system, a fully automated immunoassay analyzer. It is not a standalone device and must be paired with this analyzer to function.
Is the IMX HAVAB intended for single-use or repeated use, and what storage requirements apply?
The IMX HAVAB is intended for single-use only. While it does not require special storage conditions beyond those outlined in its instructions, standard laboratory practices for reagent storage should be followed to maintain its integrity.
What regulatory approval does the IMX HAVAB hold, and where is it authorized for use?
The IMX HAVAB holds an FDA Premarket Approval (PMA) under PMA number P780012, with regulatory compliance under 21 CFR 866.3310. Its use is authorized exclusively for qualified microbiology laboratories and healthcare settings equipped with the IMx system.
Are there different sizes or models of the IMX HAVAB, or is it a single standardized test kit?
The IMX HAVAB is described as a single reagent kit for the IMx system, with no mention of multiple sizes or models in the provided data. It is a standardized test designed for consistent use across compatible systems.