Identity
- Trade Name
- Xpert MTB/RIF FDA UDI
- Generic Name
- MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Xpert MTB/RIF kit; 10 test kit FDA UDI
- Model / Reference
- GXMTB/RIF-US-10 FDA UDI
- Description
- Xpert MTB/RIF kit; 10 test kit FDA UDI
Identifiers
- Catalog Number
- GXMTB/RIF-US-10 FDA UDI
- Primary DI / UDI-DI
- 07332940000912 FDA UDI
- FDA Product Code
- PEU FDA UDI
- GMDN Term
- MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3373 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: MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert MTB/RIF by Cepheid — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 09520b37-90cc-4328-b145-8891f3a588fe 37 fields · synced May 30, 2026