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

VALIDATE® SP1 Test Set

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

Basic Information

Primary DI
00859110005883
Basic UDI-DI Code
B-00859110005883
Reference
601bcs
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

VALIDATE SP1 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: α1-Antitrypsin (AAT), complement C3 (C3), complementC4 (C4), immunoglobulin A (IgA), immunoglobulin G (IgG), immunoglobulin M (IgM) and transferrin (TRF).

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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