Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit

Primary DI

06971042229671

Basic UDI-DI Code

B-06971042229671

Reference

E-OD-0022-02-24

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

SHANGHAI ZJ BIO-TECH CO., LTD

The Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit is used for the detection and quantitation of CMV DNA in human plasma by using real time PCR systems. Based on Real-time PCR technology, Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit is considered as an aid in the diagnosis of HCMV infection in the general population. The results with Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit must be interpreted within the context of all relevant clinical and laboratory findings. The Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit is not intended for use as an aid in the diagnosis and management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. The Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit is also not intended for use as a screening test for the presence of HCMV blood or blood products.

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).