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Cambridge Biotech HIV-1 Urine Western Blot 98078

by Maxim Biomedical Inc.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00869978000012 UDI-DI Date19 Jun 2019ListedStatusListed 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  • Withdrawn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
Cambridge Biotech HIV-1 Urine Western Blot
Generic Name
CD4 cell marker IVD, kit, rapid ICT, clinical
Model / Reference
98078
Primary DI / UDI-DI
00869978000012
FDA Product Code
MZF
GMDN Term
CD4 cell marker IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
866.3956
GUDID distribution status
In Commercial Distribution

Related devices

Category: CD4 cell marker IVD, kit, rapid ICT, clinical

Similar devices

Also classified as CD4 cell marker IVD, kit, rapid ICT, clinical.

Other devices from Maxim Biomedical Inc.

Properties

  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No