Identity
- Trade Name
- Xpert® FDA UDI
- Generic Name
- General specimen collection kit IVD, clinical FDA UDI
- Device Name
- Swab Specimen Collection Kit FDA UDI
- Model / Reference
- SWAB/G-50-US FDA UDI
- Description
- Swab Specimen Collection Kit FDA UDI
Identifiers
- Catalog Number
- SWAB/G-50-US FDA UDI
- Primary DI / UDI-DI
- 07332940008345 FDA UDI
- FDA Product Code
- PQA FDA UDIQBD FDA UDI
- GMDN Term
- General specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3975 FDA UDI866.2950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: General specimen collection kit IVD, clinical
Xpert® by Cepheid — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cepheid
Sources (1)
- FDA UDI 1c54ddc0-3b11-4682-bd7b-6312120bca2e 36 fields · synced May 30, 2026