Identity
- Trade Name
- US Biotek Laboratories FDA UDI
- Generic Name
- Urine specimen collection kit IVD FDA UDI
- Device Name
- Single-use convenient dried urine collection kit includes dry urine card and return packing for mailing to testing laboratory. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- Single-use convenient dried urine collection kit includes dry urine card and return packing for mailing to testing laboratory. FDA UDI
Identifiers
- Catalog Number
- DUK001 FDA UDI
- Primary DI / UDI-DI
- 00860010959206 FDA UDI
- FDA Product Code
- OIE FDA UDI
- GMDN Term
- Urine specimen collection kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
Yes
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: Urine specimen collection kit IVD
US Biotek Laboratories by Us Biotek Laboratories — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Us Biotek Laboratories
Sources (1)
- FDA UDI 4c8a4188-dc0e-4fef-a618-71257605b852 34 fields · synced May 30, 2026