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GENCHEM™ Amylase Reagent GEN-AMY

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 Number00851445007044 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  • Withdrawn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™ Amylase Reagent
Generic Name
Alpha-amylase isoenzyme IVD, kit, spectrophotometry
Model / Ref / Catalog
GEN-AMY
Primary DI / UDI-DI
00851445007044
FDA Product Code
JFJ
GMDN Term
Alpha-amylase isoenzyme IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
862.1070
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