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BD GeneOhm™ StaphSR assay 48 TestsA 441448

by Geneohm Sciences Canada 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382904414481 UDI-DIDate10 Aug 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  • Withdrawn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
BD GeneOhm™ StaphSR assay 48 TestsA
Generic Name
MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
441448
Primary DI / UDI-DI
00382904414481
FDA Product Code
NQX
GMDN Term
MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
Class II
Regulation Number
866.1640
GUDID distribution status
Not in Commercial Distribution

Other devices from Geneohm Sciences Canada 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