Identity
- Trade Name
- Sperm-TIC 1:20 plus FDA UDI
- Generic Name
- Sperm concentration indicator IVD, reagent FDA UDI
- Device Name
- For microscopic counting of Sperms. (100 Tests) FDA UDI
- Model / Reference
- 003604-6100 FDA UDI
- Description
- For microscopic counting of Sperms. (100 Tests) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061609000026 FDA UDI
- FDA Product Code
- JCG FDA UDI
- GMDN Term
- Sperm concentration indicator IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8200 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sperm concentration indicator IVD, reagent
Sperm-TIC 1:20 plus by BIOANALYTIC GmbH, biomed. Analysentechnik — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sperm concentration indicator IVD, reagent.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BIOANALYTIC GmbH, biomed. Analysentechnik
Sources (1)
- FDA UDI 1c81a873-de5e-4578-b0b7-4d14c230887c 33 fields · synced Jun 1, 2026