Identity
- Trade Name
- Xpert SA Nasal Complete FDA UDI
- Generic Name
- MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Xpert SA Nasal Complete kit; 10 test kit FDA UDI
- Model / Reference
- GXSACOMP-10 FDA UDI
- Description
- Xpert SA Nasal Complete kit; 10 test kit FDA UDI
Identifiers
- Catalog Number
- GXSACOMP-10 FDA UDI
- Primary DI / UDI-DI
- 07332940000158 FDA UDI
- FDA Product Code
- NQX FDA UDI
- GMDN Term
- MRSA/MSSA 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: MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert SA Nasal Complete by Cepheid — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT).
- MRSA/SA ELITe MGB — ELITechGroup MDX LLC. · Class II
- cobas® MRSA/SA Test — Roche Molecular Systems, Inc. · Class II
- cobas® MRSA/SA Test — Roche Molecular Systems, Inc. · Class II
- cobas® MRSA/SA Controls and Cofactor Kit — Roche Molecular Systems, Inc. · Class II
- Staph ID/R Blood Culture Panel — Great Basin Scientific, Inc. · Class II
- BD MAX™ StaphSR — BECTON DICKINSON AND COMPANY · Class II
- Xpert MRSA/SA Blood Culture — CEPHEID · Class II
- Xpert MRSA/SA SSTI — CEPHEID · Class II
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 3b15b21d-192d-45b7-b91f-49f09ea1fc75 37 fields · synced Jun 8, 2026