VALIDATE® TDM1 Test Set

Primary DI

00859110005005

Basic UDI-DI Code

B-00859110005005

Reference

301ab

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

LGC Clinical Diagnostics, Inc.

VALIDATE TDM1 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, semiautomated and manual instrument systems for the following analytes: acetaminophen (ACTM), amikacin (AMIK), carbamazepine (CARB), digoxin (DIGN), gentamicin (GENT), N-acetylprocainamide (NAPA), Phenobarbital (PHNO), phenytoin (PHYT), procainamide (PROC), quinidine (QUIN), salicylate (SALY), theophylline (THEO), tobramycin (TOB), valproic acid (VALP) and vancomycin (VANC).

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).