Identity
- Trade Name
- Men's Rapid Fertility Test FDA UDI
- Generic Name
- Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing FDA UDI
- Device Name
- Men's Rapid Fertility Test, QC Kit FDA UDI
- Model / Reference
- TQK-0-1 FDA UDI
- Description
- Men's Rapid Fertility Test, QC Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001286533 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
- 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
Category: Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing
Men's Rapid Fertility Test by Medtox Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sperm concentration indicator IVD, kit, rapid colorimetric, self-testing.
- Men's Rapid Fertility Test — MEDTOX DIAGNOSTICS, INC. · Class II
- Men's Rapid Fertility Test — MEDTOX DIAGNOSTICS, INC. · 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
- Medtox Diagnostics, Inc.
Sources (1)
- FDA UDI d106a9aa-84fd-4464-a5cb-e53da07b8d7f 33 fields · synced Jun 8, 2026