VALIDATE® CM3 Test Set

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 409ro

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name: VALIDATE® CM3 Test Set EUDAMED
Validate FDA UDI
Generic Name: Multiple cardiac marker IVD, control FDA UDI
Device Name: VALIDATE® CM3 Test Set EUDAMED
VALIDATE CM3 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for the following analytes: homocysteine (HCY) and lipoprotein (a) (LP(a)). Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 3.0 milliliters. There exists a linear relationship among Levels 1 through 5. FDA UDI
Model / Reference: 409ro EUDAMEDFDA UDI
Description: VALIDATE CM3 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for the following analytes: homocysteine (HCY) and lipoprotein (a) (LP(a)). Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 3.0 milliliters. There exists a linear relationship among Levels 1 through 5. FDA UDI

Identifiers

Catalog Number: 409ro FDA UDI
Primary DI / UDI-DI: 00850011135204 EUDAMEDFDA UDI
Basic UDI-DI: B-00850011135204 EUDAMED
FDA Product Code: JJY FDA UDI
EMDN Code: W0102152004 CARDIAC MARKER CONTROLS EUDAMED
GMDN Term: Multiple cardiac marker IVD, control FDA UDI

Classification

Device Class: Class IVD General EUDAMED
Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

VALIDATE® CM3 Test Set by LGC Clinical Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-00850011135204	Class IVD General	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IVD General	Pending data

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Manufacturer

Manufacturer: LGC Clinical Diagnostics, Inc.
EUDAMED SRN: US-MF-000029697
Authorised Representative: MediMark Europe Sarl. FR-AR-000000182

Sources (2)

EUDAMED baec1a74-2488-4b9b-a246-42cec6f45650 61 fields · synced Jul 9, 2026
FDA UDI 770a8ee4-792a-4524-9159-725274e0aad2 37 fields · synced May 30, 2026