Skip to content

GENCHEM™ Total Bilirubin Reagent GEN-TBILI R1

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 Number00851445007266 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  • Withdrawn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™ Total Bilirubin Reagent
Generic Name
Total bilirubin IVD, kit, enzyme spectrophotometry
Model / Ref / Catalog
GEN-TBILI R1
Primary DI / UDI-DI
00851445007266
FDA Product Code
CIG
GMDN Term
Total bilirubin IVD, kit, enzyme spectrophotometry
Device Class
Class II
Regulation Number
862.1110
GUDID distribution status
Not in Commercial Distribution

Other devices from Genchem Inc

See all devices from Genchem Inc →

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