Identity
- Trade Name
- URINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2) FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- This product is intended for in vitro diagnostic use, in the quality control of urine test strips. FDA UDI
- Model / Reference
- UC5034 FDA UDI
- Description
- This product is intended for in vitro diagnostic use, in the quality control of urine test strips. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273207590 FDA UDI
- FDA Product Code
- JJW FDA UDI
- GMDN Term
- Multiple urine analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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: Multiple urine analyte IVD, control
Urinalysis Control - Level 2 (urnal Control 2) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- qUAntify — Bio-Rad Laboratories · Class I
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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 0a807886-89df-48ad-9a8b-f1b0f0284dc1 35 fields · synced Jun 1, 2026