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Sign in to claim this brandAffymetrix, Inc.
United States·US-MF-000028847
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3450 Central Expressway, Santa Clara, United States
- Website
- thermofisher.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Jody Schulz
- EUDAMED SRN
- US-MF-000028847
- FDA FEI Number
- 3003314809
- DUNS Number
- 804682573
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Affymetrix | 00-0146 | FDA UDI | Class II | Active |
| Affymetrix | 1.2 | FDA UDI | Class II | Active |
| Affymetrix | 520969 | FDA UDI | Class II | Active |
| Affymetrix | 1.2 | FDA UDI | Class II | Active |
| Affymetrix | 2.1 | FDA UDI | Class II | Active |
| Affymetrix Gene Profiling Reagents | K103112 | FDA 510(k) | Class II | Active |
| Modification To Affymetrix Genechip Microarray Instrumentation System | K080995 | FDA 510(k) | Class II | Active |
| Affymetrix Genechip Microarray Instrumentation System | DEN040012 | FDA 510(k) | Class II | Active |
| CytoScan Dx Post-PCR 15°-30°C MOD E PW | 902111 (902420) | EUDAMEDFDA UDI | Class C | Active |
| GeneChip™ Scanner 3000Dx v.2 with AutoLoaderDx v2 | 00-0336 (00-0334) | EUDAMEDFDA UDI | Class A | Active |
| CytoScan Dx Pre-PCR -20°C MOD R L A | 902107 (902420) | EUDAMEDFDA UDI | Class C | Active |
| CytoScan Dx Post-PCR -20°C MOD F L H | 902109 (902420) | EUDAMEDFDA UDI | Class C | Active |
| CytoScan Dx Wash Solution B | 902091 (902420) | EUDAMEDFDA UDI | Class C | Active |
| GeneChip™ Fluidics Station FS450Dx v.2 | 00-0335 (00-0334) | EUDAMEDFDA UDI | Class A | Active |
| GCDC Dx Installer v1.0 | 611403 (00-0334) | EUDAMEDFDA UDI | Class A | Active |
| CytoScan Dx Pre-PCR 2°-8°C MOD T E W | 902108 (902420) | EUDAMEDFDA UDI | Class C | Active |
| CytoScan Dx Post-PCR 2°-8°C MOD S AH W PB | 902110 (902420) | EUDAMEDFDA UDI | Class C | Active |
| CytoScan Dx Wash Solution A | 902090 (902420) | EUDAMEDFDA UDI | Class C | Active |
| Chromosome Analysis Suite Dx Software (ChAS Dx) | 610525 | EUDAMEDFDA UDI | Class C | Active |
| CytoScan Dx Array, 6 pk | 902150 (902420) | EUDAMEDFDA UDI | Class C | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 14, 2016 | Z-1909-2016 | — | terminated | During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment. |
| Apr 26, 2005 | Z-0853-06 | — | terminated | Incorrect software version of instrument controller is not compatible with new configuration. This incorrect configuration may cause the instrument system to fail at start-up or during a run. |