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Covid ELISA Test for the Detection of IgG Antibodies - India CDSCO Medical Device Registration

Covid ELISA Test for the Detection of IgG Antibodies is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000083_3577e3a8042d3eeac49c224946ce5bd0_461554fcc50a35c781bf5c73eca2894c. This device is marketed under the brand name Q-Line. The license holder is POCT Services Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered
Class Class C
Covid ELISA Test for the Detection of IgG Antibodies
UID: MFG/IVD/2020/000083_3577e3a8042d3eeac49c224946ce5bd0_461554fcc50a35c781bf5c73eca2894c

Brand Name

Q-Line

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Q-lisa- Covid is an in-vitro qualitative enzyme immunoassay for the detection of IgG class of antibodies to SARS-CoV-2 in human serum or plasma. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion

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