Eu Ivdd Eu Ivd General On The Market 🇺🇸 United States

VALIDATE® GC3 Test Set

LGC Clinical Diagnostics, Inc. · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1

Basic Information

Primary DI
00859110005401
Basic UDI-DI Code
B-00859110005401
Reference
1300vt
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

VALIDATE GC 3 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: alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase (AMY), aspartate aminotransferase (AST), creatine kinase (CK), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LD) and lipase (LIP).

CND Nomenclature Codes

Code Description
W0101050102 UNASSAYED MULTICOMPONENT CONTROLS (CC)
W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC)

Certificates

Type Number
IVDD Annex IV (excluding sections 4, 6) 3822623

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