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Diagnostic BioSystems PDRM002-S

by Diagnostic BioSystems

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 Number00846405015955 UDI-DI Date7 Jun 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  • Withdrawn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
Diagnostic BioSystems
Generic Name
Uroplakin IVD, antibody
Model / Reference
PDRM002-S
Description
Uroplakin II and III Cocktail, Clone- AU1 and Rabbit Polyclonal ,2ml
Primary DI / UDI-DI
00846405015955
FDA Product Code
NJT
GMDN Term
Uroplakin IVD, antibody
Device Class
Class I
Regulation Number
864.1860
GUDID distribution status
In Commercial Distribution

Other devices from Diagnostic BioSystems

See all devices from Diagnostic BioSystems →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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