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Affymetrix 2.1

by Affymetrix, Inc.

Affymetrix 2.1 (610533) is a microarray analyser IVD (FDA Class II; FDA product code NSU, Instrumentation For Clinical Multiplex Test Systems) made by Affymetrix, Inc., listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00856826006050), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856826006050 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Affymetrix
Generic name
Microarray analyser IVD
Model / Ref / Catalog
2.1, 610533
Primary DI / UDI-DI
00856826006050
FDA product code
NSU
GMDN term
Microarray analyser IVD
Device class
Class II
Regulation number
862.2570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Microarray analyser IVD

Similar devices

Other devices filed under FDA product code NSU (Instrumentation For Clinical Multiplex Test Systems).

Other devices from Affymetrix, Inc.

See all devices from Affymetrix, Inc. →

Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)