Cardiac Marker Control FD Level 1&2

Primary DI

08809317540283

Basic UDI-DI Code

B-08809317540283

Reference

FIC-CMFD

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

NanoEntek, Inc.

The Cardiac Marker Control FD Level 1 & 2 is prepared from human serum with added constituents of human and animal origin, chemicals, stabilizers and preservatives. The control material is provided in lyophilized solid pellet. Level 1 & 2 containing myoglobin, cTnI, CK-MB, BNP and D- dimer in lyophilized solid pellet. The concentrations and the acceptable range of each control materials are specified in the following table.

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