Identity
- Trade Name
- T2Dx® QCheck Negative Kit FDA UDI
- Generic Name
- Multiple Candida species nucleic acid IVD, control FDA UDI
- Device Name
- Negative Control FDA UDI
- Model / Reference
- 85-08376 FDA UDI
- Description
- Negative Control FDA UDI
Identifiers
- Primary DI / UDI-DI
- M70885083763 FDA UDI
- 510(k) Number
- DEN140019 FDA UDI
- FDA Product Code
- PII FDA UDI
- GMDN Term
- Multiple Candida species nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3960 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
Dimensions & Sizes
- Size
- Total Volume — 4 Milliliter FDA UDI
Category: Multiple Candida species nucleic acid IVD, control
T2Dx® QCheck Negative Kit by T2biosystems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple Candida species nucleic acid IVD, control.
- Fort Worth Diagnostics — FORT WORTH DIAGNOSTICS LLC · Class I
- T2Candida® QCheck Positive Kit — T2biosystems, Inc. · Class II
- T2Candida® External Controls — T2biosystems, Inc. · Class II
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 1f2b9f62-5067-4a96-a216-5399e527448e 37 fields · synced May 30, 2026