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Affymetrix 1.2

by Affymetrix, Inc. 2 variants

Affymetrix 1.2 (610525) is a human genomic analysis interpretive software (FDA Class II; FDA product code PFX) made by Affymetrix, Inc., listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00856826006074), 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 Number00856826006074 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  • Withdrawn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
Human genomic analysis interpretive software
Model / Ref / Catalog
1.2, 610525
Primary DI / UDI-DI
00856826006074
FDA product code
PFX
GMDN term
Human genomic analysis interpretive software
Device class
Class II
Regulation number
866.5920
GUDID distribution status
In Commercial Distribution

Related devices

Category: Human genomic analysis interpretive software

Other devices from Affymetrix, Inc.

See all devices from Affymetrix, Inc. →

Properties

  • Manufacturing date
Other properties (14, all answered No)