Identity
- Trade Name
- Xpert CT/NG FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Xpert CT/NG kit; 10 test kit FDA UDI
- Model / Reference
- GXCT/NG-10 FDA UDI
- Description
- Xpert CT/NG kit; 10 test kit FDA UDI
Identifiers
- Catalog Number
- GXCT/NG-10 FDA UDI
- Primary DI / UDI-DI
- 07332940000080 FDA UDI
- FDA Product Code
- QEP FDA UDI
- GMDN Term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3393 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-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert CT/NG by Cepheid — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).
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- Aptima Combo 2® — Hologic, Inc. · Class II
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- Aptima Combo 2® — Hologic, Inc. · Class II
- cobas CTNG Positive Control Kit — Roche Molecular Systems, Inc. · 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 e627ada0-ac9c-4ee6-bf76-96f350c913fe 36 fields · synced May 30, 2026