Abbott AFP
by Abbott Laboratories PMA
Active
PMA P780005
Overview
Abbott AFP is a Kit, Test, Alpha-Fetoprotein For Neural Tube Defects, classified as a Class III in vitro diagnostic device. It is designed to detect alpha-fetoprotein levels in serum as a screening aid for neural tube defects such as spina bifida and anencephaly.
The device is supplied as a test kit for laboratory use and is intended for professional in vitro diagnostic applications. It received FDA PMA approval (P780005) on April 24, 1985, and is manufactured by Abbott Laboratories in Abbott Park, Illinois. The kit's authorization is based on its specific formulation and intended use as defined in the premarket approval.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP780005 | Date24 Apr 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- PMA Number
- FDA Product Code
- LOK
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Other devices from Abbott Laboratories
Questions
What is the Abbott AFP device used for?
The Abbott AFP device is an in vitro diagnostic kit used to detect alpha-fetoprotein in serum samples. It serves as a screening tool for neural tube defects such as spina bifida and anencephaly during pregnancy. This use is defined in its generic name and FDA classification as a Kit, Test, Alpha-Fetoprotein For Neural Tube Defects.
Who manufactures the Abbott AFP test kit and where is it made?
The Abbott AFP test kit is manufactured by Abbott Laboratories. The manufacturer's address is listed as 100 Abbott Park Rd., Dept 9va Ap6c-2, Abbott Park, IL 60064, United States. This information is part of the device's PMA submission and establishment registration details.
What regulatory pathway was used for the Abbott AFP device?
The Abbott AFP device received approval through the FDA Premarket Approval (PMA) pathway. The PMA number is P780005, with a decision date of April 24, 1985, and a decision code of APPR indicating approval. This is the highest level of regulatory review for medical devices in the United States.