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Anti-CDK4 AMB80-5M

by Biogenex Laboratories, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840542220906 UDI-DI Date23 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Anti-CDK4
Generic Name
Cyclin-dependent kinase 4 (CDK4) IVD, antibody
Model / Ref / Catalog
AMB80-5M
Primary DI / UDI-DI
00840542220906
FDA Product Code
NJT
GMDN Term
Cyclin-dependent kinase 4 (CDK4) IVD, antibody
Device Class
Class I
Regulation Number
864.1860
GUDID distribution status
In Commercial Distribution

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Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No