Identity
- Trade Name
- Fertility Solutions FDA UDI
- Generic Name
- Sperm concentration indicator IVD, control FDA UDI
- Device Name
- Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 150 µL each, 2 levels - positive and negative. https://www.fertilitysolutions.com/product-category/post-vasectomy-quality-control FDA UDI
- Model / Reference
- FSI211 FDA UDI
- Description
- Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 150 µL each, 2 levels - positive and negative. https://www.fertilitysolutions.com/product-category/post-vasectomy-quality-control FDA UDI
Identifiers
- Catalog Number
- FSI211 FDA UDI
- Primary DI / UDI-DI
- 00860010518137 FDA UDI
- FDA Product Code
- NRF FDA UDI
- GMDN Term
- Sperm concentration indicator IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sperm concentration indicator IVD, control
Fertility Solutions by Fertility Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Fertility Solutions, Inc.
Sources (1)
- FDA UDI e323a50c-5774-47e0-a0c8-71cdc6e3d1d0 37 fields · synced Jun 7, 2026