Identity
- Trade Name
- Leucoscreen Test Kit FDA UDI
- Generic Name
- White blood cell count IVD, kit, cell count FDA UDI
- Device Name
- Leucoscreen Test Kit, 20 tests per kit FDA UDI
- Model / Reference
- 15421 FDA UDI
- Description
- Leucoscreen Test Kit, 20 tests per kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00805360017992 FDA UDI
- GMDN Term
- White blood cell count IVD, kit, cell count FDA UDI
Classification
- Commercial Distribution
- Not 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
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
Leucoscreen Test Kit by Vitrolife AB — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Vitrolife AB
Sources (1)
- FDA UDI 018c4d33-ee7c-4d1d-a4b1-d3c319482e84 34 fields · synced May 31, 2026