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Liquid Bilirubin Control - Level 2 (liq Bil Control 2)
FDA UDIFDA 510(k)Class I (US FDA UDI)
510(k) K973995
Identity
- Trade Name
- LIQUID BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2) FDA UDI
- Generic Name
- Total bilirubin IVD, control FDA UDI
- Model / Reference
- BR10173 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273215182 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Total bilirubin 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
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
Category: Total bilirubin IVD, control
Liquid Bilirubin Control - Level 2 (liq Bil Control 2) by Randox Laboratories, Ltd. — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k)
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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 | K973995 | Class I | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (2)
- FDA UDI 11c7f68e-8b90-45a1-8108-9955868a0a0a 56 fields · synced Jun 18, 2026
- FDA 510(k) K973995 1 fields · synced Jun 4, 2026