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GeneXpert®
EUDAMEDFDA UDIClass A (EU MDR)
Ref GeneXpert IV (GX-IV)-RSRef GX-INFINITY 48S
by Cepheid
Identity
- Trade Name
- GeneXpert® EUDAMEDFDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- GeneXpert® Dx Systems EUDAMEDGeneXpert® Infinity Systems EUDAMEDXpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 FDA UDI
- Model / Reference
- GeneXpert IV (GX-IV)-RS EUDAMEDGX-INFINITY 48S EUDAMEDFDA UDI
- Description
- Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 FDA UDI
Identifiers
- Catalog Number
- GX-INFINITY 48S FDA UDI
- Primary DI / UDI-DI
- 07332940009694 EUDAMED07332940007713 EUDAMEDFDA UDI
- Basic UDI-DI
- 081164701-GX-X5 EUDAMED081164701-INFINITY-ZH EUDAMED
- FDA Product Code
- OOI FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Sweden EUDAMEDNetherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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
Category: Nucleic acid sample preparation instrument IVD
GeneXpert® by Cepheid — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081164701-GX-X5 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Cepheid
- EUDAMED SRN
- US-MF-000010979
- Authorised Representative
- Cepheid AB SE-AR-000048904
Sources (3)
- EUDAMED c78f35c6-bf89-4268-90d3-7991815145f7 61 fields · synced Jul 17, 2026
- EUDAMED 0ad11ab0-671d-499a-a8cd-2ea503cb2a26 61 fields · synced May 18, 2026
- FDA UDI bda8b10c-7be9-4739-af4f-6b08b50226ea 36 fields · synced May 30, 2026