Identity
- Trade Name
- Portrait Toxigenic C. difficile Assay FDA UDI
- Generic Name
- Clostridium difficile toxin B nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- C. diff Assay Cartridge and Sample Prep Device. FDA UDI
- Model / Reference
- GBCDIFF-10 FDA UDI
- Description
- C. diff Assay Cartridge and Sample Prep Device. FDA UDI
Identifiers
- Catalog Number
- GBCDIFF-10 FDA UDI
- Primary DI / UDI-DI
- B178GBCDIFF100 FDA UDI
- FDA Product Code
- OZN FDA UDIOMN FDA UDI
- GMDN Term
- Clostridium difficile toxin B nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3130 FDA UDI866.2660 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
No
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: Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)Clostridium difficile toxin B nucleic acid IVD, kit, nucleic acid technique (NAT)
Portrait Toxigenic C. difficile Assay by Great Basin Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT).
- BD MAX™ Cdiff (US) — BECTON DICKINSON AND COMPANY · Class II
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- Toxigenic C. difficile Direct Test — Vela Operations USA · Class II
- Toxigenic C. difficile Direct Test - Sample Prep — Vela Operations USA · Class II
- Simplexa™ C.difficile Sample Prep Kit — DiaSorin Molecular LLC · Class II
- Xpert C. difficile — CEPHEID · Class I
- Lyra — Quidel Corp. · 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
- Great Basin Scientific, Inc.
Sources (1)
- FDA UDI e9e7e8d7-7858-4547-96d9-9009bcb4e1ff 36 fields · synced May 31, 2026