Identity
- Trade Name
- T2Candida® Cartridge Kit FDA UDI
- Generic Name
- Multiple Candida species nucleic acid IVD, reagent FDA UDI
- Device Name
- The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel. FDA UDI
- Model / Reference
- 90-01794 FDA UDI
- Description
- The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M70890017940 FDA UDI
- 510(k) Number
- DEN140019 FDA UDI
- FDA Product Code
- PII FDA UDI
- GMDN Term
- Multiple Candida species nucleic acid IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3960 FDA UDI
- Commercial Distribution
- Not 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
T2Candida® Cartridge Kit by T2biosystems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- T2biosystems, Inc.
Sources (1)
- FDA UDI f55b13d5-814e-4e8a-83e1-3e90961c55d9 37 fields · synced May 30, 2026