Affymetrix, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000028847 FEI 3003314809
Affymetrix, Inc. is a medical device manufacturer based in the United States, with 20 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class C and A; FDA Class II) and 2 FDA recalls as of 15 Nov 2026.
- Devices
- 20
- Registrations
- EUDAMEDFDA
- FDA recalls
- 2
Registry facts
- Registries
- FDA GUDID 17
- EUDAMED 12
- FDA 510(k) 3
- Device classes
- EU Class C 9
- FDA Class II 8
- EU Class A 3
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Life Technologies Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000028847
- FDA FEI 3003314809
- DUNS 804682573
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Life Technologies Europe B.V.NL
What Affymetrix, Inc. makes
The company produces microarray analysers for in vitro diagnostics (IVD), including systems for human genomic analysis and interpretive software. It also offers genotyping kits and nucleic acid techniques (NAT) for identifying intellectual and developmental disabilities. Optical scanning laser microscopes and gene profiling reagents are part of its portfolio, alongside pre- and post-PCR microarray instrumentation for genetic testing.
These devices are regulated under Class A, Class C, and Class II classifications, with listings in the EU’s eudamed registry and the US FDA’s 510(k) and UDI databases. The company is based in the United States.
Catalogue
Search and filter all 20 devicesCompany details
- EUDAMED SRN
- US-MF-000028847
- FDA FEI number
- 3003314809
- DUNS number
- 804682573
- EUDAMED status
- Active
- EUDAMED registered name
- Affymetrix, Inc.
- Registered address
- 3450 Central Expressway, 95051, Santa Clara, United States
- PRRC contact
- Jody Schulz
FDA recalls
FDA recall records list 2 recalls initiated by Affymetrix, Inc., the earliest on 2005-04-26 and the most recent on 2016-04-14. By recorded status: 2 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 14 Apr 2016 Z-1909-2016 Class III Terminated During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
2005
- 26 Apr 2005 Z-0853-06 Unclassified (pre-2012) 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.
Frequently asked questions
How many devices does Affymetrix, Inc. have in the registry?
The registry currently lists 20 devices for Affymetrix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Affymetrix, Inc.'s devices?
Among its 20 most recently registered devices, Affymetrix, Inc. has devices listed in EUDAMED (12 devices), FDA 510(k) (3 devices) and FDA GUDID (17 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Affymetrix, Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Affymetrix, Inc.'s devices are Class II, IVDR Class A and IVDR Class C. Each device page shows its own class and authorisation.
Are there FDA recall records for Affymetrix, Inc.?
FDA recall records list 2 recalls initiated by Affymetrix, Inc., the most recent initiated on 14 Apr 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Affymetrix, Inc. in the registry?
The most recently registered devices listed for Affymetrix, Inc. include Affymetrix 00-0146, Affymetrix 1.2, Affymetrix 520969 and Affymetrix 2.1.