Identity
- Trade Name
- Sperm-TIC 1:20 FDA UDI
- Generic Name
- Sperm concentration indicator IVD, reagent FDA UDI
- Device Name
- For microscopic counting of Sperms. (5 Tests) FDA UDI
- Model / Reference
- 003604-6005 FDA UDI
- Description
- For microscopic counting of Sperms. (5 Tests) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061609000019 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
No
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 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 |
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Manufacturer
- Manufacturer
- BIOANALYTIC GmbH, biomed. Analysentechnik
Sources (1)
- FDA UDI c52513ac-f079-4368-b8f8-5224d6089925 33 fields · synced Jun 8, 2026