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Enzyme Immunoassay, Inhibin-A
FDA product code NDR · Class 1 · Clinical Chemistry
7
Registered devices
27
Adverse events
3
Recalls
1
510(k) clearances
Devices with this code
Inhibin A ELISA — Beckman Coulter, Inc.Access Inhibin A — Beckman Coulter, Inc.Dimension Vista® Flex® reagent cartridge E2 — Siemens Healthcare Diagnostics Inc.Dimension Vista® MULTI 1 SDIL — Siemens Healthcare Diagnostics Inc.AutoDELFIA Inhibin A kit Level Calibrators — Wallac OyInhibin A ELISA — Beckman Coulter, Inc.AutoDELFIA Inhibin A kit — Wallac Oy
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-12-21 | Beckman Coulter Inc. | The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit |
| 2010-12-21 | Beckman Coulter Inc. | The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit |
| 2010-11-10 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed the microbial contamination in the conjugate diluent bottles included in the Manual Inhibin A Eli |
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