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GENCHEM™ CK-NAC Reagent GEN-CK R2

by Genchem Inc

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851445007143 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
GENCHEM™ CK-NAC Reagent
Generic Name
Creatine kinase (CK) multiple isoenzyme IVD, reagent
Model / Ref / Catalog
GEN-CK R2
Primary DI / UDI-DI
00851445007143
FDA Product Code
CGS
GMDN Term
Creatine kinase (CK) multiple isoenzyme IVD, reagent
Device Class
Class II
Regulation Number
862.1215
GUDID distribution status
Not in Commercial Distribution

Other devices from Genchem Inc

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No