Diagnostic Kit for D-Dimer - India CDSCO Medical Device Registration

Diagnostic Kit for D-Dimer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000208_7e211a795357cac902b37538b450aea2_1acfe3af950847686b943e62f679646a. This device is marketed under the brand name MyBox SAA. The license holder is Mylab Discovery Solutions Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Diagnostic Kit for D-Dimer

UID: IMP/IVD/2023/000208_7e211a795357cac902b37538b450aea2_1acfe3af950847686b943e62f679646a

Brand Name

MyBox SAA

License Holder

Mylab Discovery Solutions Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

This kit is suitable for in vitro quantitative detection of the concentration of D-Dimer in human plasma and whole blood. This product is used for testing in medical and health institutions for the auxiliary diagnosis of disseminated intravascular coagulation and pulmonary embolism and other related diseases.