# Affymetrix, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/affymetrix-inc>
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: US-MF-000028847
- FDA FEI: 3003314809
- DUNS: 804682573

## Figures

- Devices: 20
- FDA recalls (matched to the firm by name): 2

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 17, EUDAMED 12, FDA 510(k) 3
- Device classes: EU Class C 9, FDA Class II 8, EU Class A 3
- EMDN [W01 Reagents](https://devicerts.com/categories/emdn/W01): 8 devices
- EMDN [W02 IVD instruments](https://devicerts.com/categories/emdn/W02): 4 devices

## Sites and related companies

- Authorised representative: [Life Technologies Europe B.V.](https://devicerts.com/representatives/life-technologies-europe-bv-nl-ar-000021890) (Netherlands)

## Devices

The first 20 of 20, in the order of the canonical page, which lists them all.

- [Affymetrix 00-0146](https://devicerts.com/devices/affymetrix-00-0146) · Class II · GUDID · status: Listed
- [Affymetrix 1.2](https://devicerts.com/devices/affymetrix-610525) · Class II · GUDID · status: Listed
- [Affymetrix 520969](https://devicerts.com/devices/affymetrix-520969) · Class II · GUDID · status: Listed
- [Affymetrix 1.2](https://devicerts.com/devices/affymetrix-610466) · Class II · GUDID · status: Listed
- [Affymetrix 2.1](https://devicerts.com/devices/affymetrix-610533) · Class II · GUDID · status: Listed
- [Affymetrix Gene Profiling Reagents](https://devicerts.com/devices/affymetrix-gene-profiling-reagents-ova) · ref K103112 · Class II · 510(k) · status: Active · decision 2011-05-04
- [Modification To Affymetrix Genechip Microarray Instrumentation System](https://devicerts.com/devices/modification-to-affymetrix-genechip-microarray-instrumentati-nsu) · ref K080995 · Class II · 510(k) · status: Active · decision 2008-07-30
- [Affymetrix Genechip Microarray Instrumentation System](https://devicerts.com/devices/affymetrix-genechip-microarray-instrumentation-system-nsu) · ref DEN040012 · Class II · De Novo · status: Active · decision 2004-12-23
- [CytoScan Dx Post-PCR 15°-30°C MOD E PW](https://devicerts.com/devices/cytoscan-dx-post-pcr-15deg-30degc-mod-e-pw-902111-902420) · ref 902111 (902420) · Class C · EUDAMED, GUDID · status: Active
- [GeneChip™ Scanner 3000Dx v.2 with AutoLoaderDx v2](https://devicerts.com/devices/genechip-scanner-3000dx-v-2-with-autoloaderdx-v2-00-0336-00-0334) · ref 00-0336 (00-0334) · Class A · EUDAMED, GUDID · status: Active
- [CytoScan Dx Pre-PCR -20°C MOD R L A](https://devicerts.com/devices/cytoscan-dx-pre-pcr-20degc-mod-r-l-a-902107-902420) · ref 902107 (902420) · Class C · EUDAMED, GUDID · status: Active
- [CytoScan Dx Post-PCR -20°C MOD F L H](https://devicerts.com/devices/cytoscan-dx-post-pcr-20degc-mod-f-l-h-902109-902420) · ref 902109 (902420) · Class C · EUDAMED, GUDID · status: Active
- [CytoScan Dx Wash Solution B](https://devicerts.com/devices/cytoscan-dx-wash-solution-b-902091-902420) · ref 902091 (902420) · Class C · EUDAMED, GUDID · status: Active
- [GeneChip™ Fluidics Station FS450Dx v.2](https://devicerts.com/devices/genechip-fluidics-station-fs450dx-v-2-00-0335-00-0334) · ref 00-0335 (00-0334) · Class A · EUDAMED, GUDID · status: Active
- [GCDC Dx Installer v1.0](https://devicerts.com/devices/gcdc-dx-installer-v1-0-611403-00-0334) · ref 611403 (00-0334) · Class A · EUDAMED, GUDID · status: Active
- [CytoScan Dx Pre-PCR 2°-8°C MOD T E W](https://devicerts.com/devices/cytoscan-dx-pre-pcr-2-8-c-mod-t-e-w-902108-902420) · ref 902108 (902420) · Class C · EUDAMED, GUDID · status: Active
- [CytoScan Dx Post-PCR 2°-8°C MOD S AH W PB](https://devicerts.com/devices/cytoscan-dx-post-pcr-2-8-c-mod-s-ah-w-pb-902110-902420) · ref 902110 (902420) · Class C · EUDAMED, GUDID · status: Active
- [CytoScan Dx Wash Solution A](https://devicerts.com/devices/cytoscan-dx-wash-solution-a-902090-902420) · ref 902090 (902420) · Class C · EUDAMED, GUDID · status: Active
- [Chromosome Analysis Suite Dx Software (ChAS Dx)](https://devicerts.com/devices/chromosome-analysis-suite-dx-software-chas-dx-610525) · ref 610525 · Class C · EUDAMED, GUDID · status: Active
- [CytoScan Dx Array, 6 pk](https://devicerts.com/devices/cytoscan-dx-array-6-pk-902150-902420) · ref 902150 (902420) · Class C · EUDAMED, GUDID · status: Active

## FDA recalls (matched by name, newest first)

- Z-1909-2016 · Class III · Terminated · initiated 2016-04-14 · product code PFX: During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
- Z-0853-06 · Unclassified (pre-2012) · Terminated · initiated 2005-04-26 · product code NSU: 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.

## Source and citation

- Cite as: Affymetrix, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/affymetrix-inc (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/affymetrix-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/affymetrix-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.