Identity
- Trade Name
- Tri-Tech Forensics, Inc. FDA UDI
- Generic Name
- Urine specimen collection kit IVD FDA UDI
- Device Name
- Tri-Tech Forensics Urine Specimen Collection Kit FDA UDI
- Model / Reference
- UC-1 FDA UDI
- Description
- Tri-Tech Forensics Urine Specimen Collection Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869373000235 FDA UDI
- 510(k) Number
- K952246 FDA UDI
- FDA Product Code
- JXA FDA UDI
- GMDN Term
- Urine specimen collection kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
No
FDA UDI
Over-the-Counter
Yes
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
- Height — 2.5 Inch FDA UDIWidth — 3.75 Inch FDA UDILength — 5.0 Inch FDA UDI
Category: Urine specimen collection kit IVD
Tri-Tech Forensics, Inc. by Tri-Tech Forensics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K952246 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Tri-Tech Forensics Inc.
Sources (1)
- FDA UDI fc4364e8-68cb-4218-a518-9518a771e267 35 fields · synced Jun 8, 2026