COVID-19 Antigen Self Test Kit - India CDSCO Medical Device Registration

COVID-19 Antigen Self Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_cf5a8b0c55dbe4d6fbc7c50bc29beb54_4a7a0e3ea65f523de1d23f067fcbf59e. This device is marketed under the brand name STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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CDSCO Registered

Class Class C

COVID-19 Antigen Self Test Kit

UID: MFG/MD/2018/000005_cf5a8b0c55dbe4d6fbc7c50bc29beb54_4a7a0e3ea65f523de1d23f067fcbf59e

Brand Name

STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test

License Holder

SD Biosensor Healthcare Pvt. Ltd

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

Intended to be used in symptomatic individuals suspected of having COVID-19 with symptoms of Respiratory infection are tested for the presence of SARS CoV-2 virus antigens by immunochromatography in a nasal specimen. It is an in vitro diagnostic medical device

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Dengue virus Antigen Test Kits

Brand: STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test

SD Biosensor Healthcare Pvt. Ltd

COVID-19 Antigen Self Test Kit - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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