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GeneXpert Dx System GXII-1

by Cepheid

GeneXpert Dx System GXII-1 (900-0505) is a Class II device made by Cepheid, cleared under FDA 510(k) K173263 on 9 Jan 2018 (1 earlier submission) and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 07332940001414), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173263 Date9 Jan 2018DecidedStatusActive
United StatesGUDID listing Number07332940001414 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173263 decided 9 Jan 2018 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07332940001414 listed 12 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0376-2008 FDA Unclassified (pre-2012) initiated 5 Sep 2007 on shared 510(k) K060540

    Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file)

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K060540
  2. Recall initiated FDA recalls Z-0376-2008
  3. Listed FDA GUDID 07332940001414
  4. Cleared FDA 510(k) K173263

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
GeneXpert Dx System
Generic name
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Model / Ref / Catalog
GXII-1, 900-0505
Primary DI / UDI-DI
07332940001414
510(k) Number
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
Not in Commercial Distribution

Related devices

Cleared under the same submission (K173263)

Similar devices

Other devices filed under FDA product code OOI (Real Time Nucleic Acid Amplification System).

Other devices from Cepheid

See all devices from Cepheid →

Properties

  • Serial number
Other properties (14, all answered No)