Identity
- Trade Name
- GeneXpert EUDAMEDGeneXpert® FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- GeneXpert® Dx Systems EUDAMEDXPERT, GENEXPERT DX SYSTEM FDA UDI
- Model / Reference
- GeneXpert II (GX-II) EUDAMEDGX-II R2 FDA UDI
- Description
- XPERT, GENEXPERT DX SYSTEM FDA UDI
Identifiers
- Catalog Number
- GX-II R2 FDA UDI
- Primary DI / UDI-DI
- 07332940007683 EUDAMEDFDA UDI
- Basic UDI-DI
- 081164701-GX-X5 EUDAMED
- FDA Product Code
- OOI FDA UDINJR 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 UDI866.3740 FDA UDI
- Market of Registration
- Netherlands 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 (2)
- EUDAMED 47d8cd38-5d07-4cfe-8822-4c2ad6b39e3b 61 fields · synced May 30, 2026
- FDA UDI abbeb867-b22d-4b25-b87a-b0cd09d6bff0 37 fields · synced May 29, 2026