Nucleic Acid Extraction and Purification Kit - India CDSCO Medical Device Registration

Nucleic Acid Extraction and Purification Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000170_09374125d54b5c59db4d83944ab443e0_5c7563c98a6f879a70be12d9a12f4ee3. This device is marketed under the brand name 2019-nCoV. The license holder is Gland Pharma Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Nucleic Acid Extraction and Purification Kit

UID: IMP/IVD/2020/000170_09374125d54b5c59db4d83944ab443e0_5c7563c98a6f879a70be12d9a12f4ee3

Brand Name

2019-nCoV

License Holder

Gland Pharma Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

This product is intended for the extraction, enrichment and purification of nucleic acids (2019-nCoV) from serum, plasma, whole blood, urine, sputum, cerebrospinal fluid, pleural effusion, milk, nose swab, oropharyngeal swab, nasopharyngeal swab and urogenital swab samples. The purified nucleic acid is used for molecular diagnostic application, and not intended for the direct diagnosis, prevention, or treat of a disease