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GeneXpert Dx System

FDA UDI

Class II (US FDA UDI)

by Cepheid

Identity

Trade Name
GeneXpert Dx System FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Device Name
Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXII-CLIA-L FDA UDI
Model / Reference
GXII-2 FDA UDI
Description
Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXII-CLIA-L FDA UDI

Identifiers

Catalog Number
900-0485 FDA UDI
Primary DI / UDI-DI
07332940001377 FDA UDI
510(k) Number
K060540 FDA UDI
K173263 FDA UDI
FDA Product Code
OOI FDA UDI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

GeneXpert Dx System by Cepheid — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K060540 also covers:

K173263 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cepheid

Sources (1)

  • FDA UDI 7274db95-6e22-4975-8429-4866ff9cb9d2 38 fields · synced Jun 1, 2026