Identity
- Trade Name
- US Biotek Laboratories FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, clot promoter FDA UDI
- Device Name
- Single-use convenient serum collection kit includes collection tube(s), and return packing for mailing to testing laboratory. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- Single-use convenient serum collection kit includes collection tube(s), and return packing for mailing to testing laboratory. FDA UDI
Identifiers
- Catalog Number
- SCK001 FDA UDI
- Primary DI / UDI-DI
- 00860010959268 FDA UDI
- FDA Product Code
- PQD FDA UDI
- GMDN Term
- Evacuated blood collection tube IVD, clot promoter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Evacuated blood collection tube IVD, clot promoter
US Biotek Laboratories by Us Biotek Laboratories — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Us Biotek Laboratories
Sources (1)
- FDA UDI 61455468-b475-44b7-9454-f6f0ea023086 34 fields · synced May 30, 2026