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Liquid Frozen Lipid Control - Level 3 (liq Lpd Control 3)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- LIQUID FROZEN LIPID CONTROL - LEVEL 3 (LIQ LPD CONTROL 3) FDA UDI
- Generic Name
- Multiple lipid analyte IVD, control FDA UDI
- Model / Reference
- LE10176 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273215212 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple lipid 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
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: Multiple lipid analyte IVD, control
Liquid Frozen Lipid Control - Level 3 (liq Lpd Control 3) by Randox Laboratories, Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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- Liquichek — Bio-Rad Laboratories · Class I
- Audit MicroControls Linearity FD Lipids — Aalto Scientific, Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (2)
- FDA UDI 077ce0cf-9dd4-4ef5-993b-8002fd702556 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026