Identity
- Trade Name
- Xpert Carba-R FDA UDI
- Generic Name
- Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Xpert Carba-R test; 10 test kit FDA UDI
- Model / Reference
- GXCARBAR-10 FDA UDI
- Description
- Xpert Carba-R test; 10 test kit FDA UDI
Identifiers
- Catalog Number
- GXCARBAR-10 FDA UDI
- Primary DI / UDI-DI
- 07332940001032 FDA UDI
- FDA Product Code
- POC FDA UDIPMY FDA UDI
- GMDN Term
- Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 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: Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Carba-R by Cepheid — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT).
- BD MAX™ CPO — BECTON DICKINSON AND COMPANY · Class II
- Revogene Carba C — MERIDIAN BIOSCIENCE, INC. · Class II
- Xpert vanA — CEPHEID · Class II
Cleared under the same submission
K173263 also covers:
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
- GeneXpert Dx System — CEPHEID
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cepheid
Sources (1)
- FDA UDI 210dc75b-dd1b-4a7d-961d-85d8afa14cdf 37 fields · synced May 31, 2026