CDSCO UID MFG/MD/2018/000005_b690689fc6cadbc60cb59b529a337474_db6b778405f40bb15a310f6a8dd4bdd1
Malaria Antigen test kits
SD Biosensor Healthcare Pvt. Ltd·Device Class Class C·India CDSCO·Brand: STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test
Registration details
- UID
- MFG/MD/2018/000005_b690689fc6cadbc60cb59b529a337474_db6b778405f40bb15a310f6a8dd4bdd1
- Device class
- Class C
- Brand name
- STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test
- License holder
- SD Biosensor Healthcare Pvt. Ltd
- Approving authority
- Sub Zonal Baddi
- Product information
- It is a rapid and membrane based immmunochromatography for the qualitative detection of Plasmodium falciparum (STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test) specific Histidine Rich Protein 2 (STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test) in human whole blood specimen. This test is in vitro professional diagnostic use and intended as an aid to diagnosis of the infection in patient with suspected malaria before treatment is administered. It provides only an initial screening test. Therefore, any reactive specimen with this test should be confirmed with alternative testing method such as microscopic examination of thin blood smear and clinical findings
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About this record
Malaria Antigen test kits is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_b690689fc6cadbc60cb59b529a337474_db6b778405f40bb15a310f6a8dd4bdd1. 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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