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Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA product code LOK · Class 3 · Unknown
28
Registered devices
159
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
Atellica IM AFP — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland DiagnosticsAtellica IM Calibrator D — Siemens Healthcare Diagnostics Inc.Atellica IM AFP — Siemens Healthcare Diagnostics Inc.IMMULITE® 2000 Systems AF AFP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAlinity — Abbott Ireland DiagnosticsADVIA Centaur® Calibrator D — Siemens Healthcare Diagnostics Inc.AutoDELFIA hAFP Kit — Wallac OyIMMULITE®/IMMULITE®1000 Systems AF AFP Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® AFP — Siemens Healthcare Diagnostics Inc.Access AFP Sample Diluent — Beckman Coulter, Inc.Atellica IM Calibrator D — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland DiagnosticsAccess AFP — Beckman Coulter, Inc.ADVIA Centaur® Systems, ACS:180® Systems Calibrator D — Siemens Healthcare Diagnostics Inc.IMMULITE® 2000 Systems AF AFP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®/IMMULITE®1000 Systems AF AFP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDARCHITECT — Abbott Ireland DiagnosticsADVIA Centaur® Systems, ACS:180® Systems Calibrator D — Siemens Healthcare Diagnostics Inc.Atellica IM Calibrator D — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® AFP — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® AFP — Siemens Healthcare Diagnostics Inc.Alinity — Abbott Ireland DiagnosticsAlinity — Abbott Ireland Diagnostics
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2003-06-12 | Abbott Laboratories HPD/ADD | AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5% |
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