Identity
- Trade Name
- Xpert® EUDAMEDXpert GBS FDA UDI
- Generic Name
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Xpert® GBS EUDAMEDXpert GBS kit; 10 test kit FDA UDI
- Model / Reference
- GXGBS-100N-10 EUDAMEDFDA UDI
- Description
- Xpert GBS kit; 10 test kit FDA UDI
Identifiers
- Catalog Number
- GXGBS-100N-10 FDA UDI
- Primary DI / UDI-DI
- D-07332940000127FC EUDAMED07332940000127 FDA UDI
- Basic UDI-DI
- B-07332940000127FC EUDAMED
- 510(k) Number
- K060540 FDA UDI
- FDA Product Code
- NJR FDA UDI
- EMDN Code
- W0105011104 STREP. B DETECTION BY NA REAGENTS EUDAMED
- GMDN Term
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3740 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Xpert® by Cepheid — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-07332940000127FC | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Cepheid
- EUDAMED SRN
- US-MF-000010979
- Authorised Representative
- Cepheid AB SE-AR-000048904
Sources (2)
- EUDAMED 9152155a-b982-4699-99cb-302541e05990 61 fields · synced Jul 9, 2026
- FDA UDI 495a09ce-7cd6-4433-887f-9ce579c2cae3 37 fields · synced May 30, 2026