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Lipid Control - Level 1 (lpd Control 1)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref LE2661

by Randox Laboratories Limited

Identity

Trade Name
LIPID CONTROL - LEVEL 1 (LPD CONTROL 1) EUDAMEDFDA UDI
Generic Name
Multiple lipid analyte IVD, control FDA UDI
Device Name
LIPID CONTROL EUDAMED
This product is intended for in vitro use in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), Apolipoprotein A-1, Apolipoprotein B, Cholesterol and Triglyceride methods on clinical chemistry systems. FDA UDI
Model / Reference
LE2661 EUDAMEDFDA UDI
Description
This product is intended for in vitro use in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), Apolipoprotein A-1, Apolipoprotein B, Cholesterol and Triglyceride methods on clinical chemistry systems. FDA UDI

Identifiers

Primary DI / UDI-DI
05055273204155 EUDAMEDFDA UDI
Basic UDI-DI
50552732BLPDCON080GR EUDAMED
FDA Product Code
JJY FDA UDI
EMDN Code
W0101050202 LIPID CONTROLS EUDAMED
GMDN Term
Multiple lipid analyte IVD, control FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Market of Registration
Northern Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

Lipid Control - Level 1 (lpd Control 1) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED bc016b9d-f5ae-49b3-bf35-b4de6f883e82 61 fields · synced Jul 29, 2026
  • FDA UDI fbf16ed0-9936-447e-8f96-bb6fb7f12582 35 fields · synced May 30, 2026