Identity
- Trade Name
- Trak FDA UDI
- Generic Name
- Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing FDA UDI
- Device Name
- Trak Male Fertility Testing System, 1-Test Kit FDA UDI
- Model / Reference
- TZZ-0-1C FDA UDI
- Description
- Trak Male Fertility Testing System, 1-Test Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00862105000398 FDA UDI
- FDA Product Code
- POV FDA UDI
- GMDN Term
- Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Trak by Medtox Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medtox Diagnostics, Inc.
Sources (1)
- FDA UDI 7aad0f2d-d8aa-4a99-8ae3-52c9017a900a 34 fields · synced Jun 8, 2026