One Step Test for Novel Coronavirus IgM/IgG Antibody - India CDSCO Medical Device Registration

One Step Test for Novel Coronavirus IgM/IgG Antibody is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000236_7bfe016aed2a38496ed6ab4e17b85f1c_bf9b11390ccd6411675e4d9da1fcef63. This device is marketed under the brand name Beta 2 - MG. The license holder is Cosmic Scientific Technologies, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

One Step Test for Novel Coronavirus IgM/IgG Antibody

UID: IMP/IVD/2020/000236_7bfe016aed2a38496ed6ab4e17b85f1c_bf9b11390ccd6411675e4d9da1fcef63

Brand Name

Beta 2 - MG

License Holder

Cosmic Scientific Technologies

Device Class

Class C

Approving Authority

CDSCO

Product Information

One Step Test for Novel Coronavirus (Beta 2 - MG) IgM/IgG Antibody (Beta 2 - MG) is intended for the qualitative detection of 2019-Novel Coronavirus IgM and IgG antibody in serum, plasma, fingertip blood or whole blood samples of pneumonitis patients or suspected cases.

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