VALIDATE® BODY FLUIDS Test Set

Primary DI

00859110005548

Basic UDI-DI Code

B-00859110005548

Reference

205bf

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

LGC Clinical Diagnostics, Inc.

VALIDATE BODY FLUIDS Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range on automated instrument systems for the following analytes: Set 1: albumin (ALB), amylase (AMY), cholesterol (CHOL), creatinine (CREA), glucose (GLU), lactate (LAC), lactate dehydrogenase (LD), total protein (TP), triglycerides (TRIG) and urea nitrogen (UN). Set 2: CSF Total Protein (CSF-TP).

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