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GeneXpert® GX-INFINITY 48S Refurb

by Cepheid

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 Number07332940009915 UDI-DI Date19 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  • Withdrawn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
GeneXpert®
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Model / Reference
GX-INFINITY 48S Refurb
Primary DI / UDI-DI
07332940009915
FDA Product Code
OOI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Device Class
Class II
Regulation Number
862.2570
GUDID distribution status
In Commercial Distribution

Other devices from Cepheid

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Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No