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

VALIDATE® THY Test Set

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

Basic Information

Primary DI
00850011135174
Basic UDI-DI Code
B-00850011135174
Reference
901bc
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

VALIDATE THY 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: THY Set: cortisol (COR), triiodothyronine (T3), thyroxine (T4) and human thyroid stimulating hormone (TSH). FT4 Set: free thyroxine (FT4). The THY Set also contains free triiodothyronine (FT3) as an element of the Total T3 component.

CND Nomenclature Codes

Code Description
W0102152002 HORMONE CONTROLS

Certificates

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

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