BioCLIA Autoimmune Reagent Kit, PCA

Primary DI

06924030415921

Basic UDI-DI Code

B-06924030415921

Reference

MY00145C

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

HOB Biotech Group Corp., Ltd.

The BioCLIA Autoimmune Reagent Kit, PCA assay is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to parietal cell in human serum and plasma as an aid in the diagnosis of pernicious anemia (PA). It is an in vitro diagnostic medical device intended for laboratory professional use. The BioCLIA Autoimmune Calibrator Set, PCA is intended for the calibration of the BioCLIA PCA performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, PCA is intended for the quality control purposes of the BioCLIA PCA performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.

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