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General Purpose Reagent Delayed Semen Analysis Media
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- General Purpose Reagent Delayed Semen Analysis Media FDA UDI
- Generic Name
- Home semen collection kit IVD FDA UDI
- Device Name
- Delayed Semen Analysis Collection Cup and Pipette FDA UDI
- Model / Reference
- PPM FDA UDI
- Description
- Delayed Semen Analysis Collection Cup and Pipette FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868586000285 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Home semen collection kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Home semen collection kit IVD
General Purpose Reagent Delayed Semen Analysis Media by Quest Diagnostics — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Quest Diagnostics
Sources (1)
- FDA UDI 50e1b68e-1acb-48f5-a772-f3b6ec3ccd47 33 fields · synced May 29, 2026