FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
PMA: P930036
·
Supplement: S021
·
Decision Feb 8, 2024
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
- Trade Name
- Atellica IM Alpha Fetoprotein (AFP)
- PMA Number
- P930036
- Supplement Number
- S021
- Device Class
- FDA Class 3
- Product Code
- LOK
- Generic Name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 8, 2024
- Date Received
- August 14, 2023
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
migration of the ADVIA Centaur AFP assay to the Atellica CI Analyzer
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOK | Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | FDA class 3 | Unknown |