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SARS-CoV-2 Antibody Rapid Test - India CDSCO Medical Device Registration

SARS-CoV-2 Antibody Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000113_d369ba60683bfbff2f4f15d5c84f4ea0_546f73f25c6b5ded63db70367835bc49. This device is marketed under the brand name Chimera. The license holder is CHIMERA BIOTECH PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is South Delhi Division.

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CDSCO Registered
Class Class B
SARS-CoV-2 Antibody Rapid Test
UID: MFG/IVD/2023/000113_d369ba60683bfbff2f4f15d5c84f4ea0_546f73f25c6b5ded63db70367835bc49

Brand Name

Chimera

Device Class

Class B

Approving Authority

South Delhi Division

Product Information

The Chimeraยฎ SARS-CoV-2 Antibody Rapid is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies to SARS-CoV-2 in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with SARS-CoV-2. Prolonged fever, fatigue, headache, cough, shortness of breathing, nausea, sore throat, loss of taste or smell, congestion or runny nose and diarrhoea

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