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US IVD-HCCA Matrix, Portioned 10 Tubes 8604531

by Bruker Scientific LLC

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10841594110013 UDI-DI Date16 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  • Withdrawn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
US IVD-HCCA Matrix, Portioned 10 Tubes
Generic Name
Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD
Model / Ref / Catalog
8604531
Primary DI / UDI-DI
10841594110013
FDA Product Code
PEX
GMDN Term
Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD
Device Class
Class II
Regulation Number
866.3361
GUDID distribution status
Not in Commercial Distribution

Properties

Other properties (14)

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