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Liquid Urine Control - Level 2 (liq Urn Control 2)
FDA UDIFDA 510(k)Class I (US FDA UDI)
510(k) K043266
Identity
- Trade Name
- LIQUID URINE CONTROL - LEVEL 2 (LIQ URN CONTROL 2) FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- The Randox Liquid Urine Control Level 2 is intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems. The Liquid Urine Control is for the control of accuracy. FDA UDI
- Model / Reference
- UC5074 FDA UDI
- Description
- The Randox Liquid Urine Control Level 2 is intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems. The Liquid Urine Control is for the control of accuracy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273207569 FDA UDI
- FDA Product Code
- JJY 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
Liquid Urine Control - Level 2 (liq Urn Control 2) by Randox Laboratories, Ltd. — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k)
Similar devices
Also classified as Multiple urine analyte IVD, control.
- Mission Liquid Urine Controls — ACON Laboratories, Inc. · Class I
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- iChem® VELOCITY™ — BECKMAN COULTER IRELAND INC. · Class I
- ABX PENTRA URINE CONTROL L/H — Horiba Abx · Class I
- K-ASSAY® Microalbumin Urine Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL — QUANTIMETRIX CORP. · Class I
- qUAntify — Bio-Rad Laboratories · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043266 | Class I | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (2)
- FDA UDI e2897b01-d193-4ff3-aeb9-457b0409ea8c 59 fields · synced Jun 18, 2026
- FDA 510(k) K043266 1 fields · synced Jun 4, 2026