Professional Documents
Culture Documents
Individually sealed
devices may or may Sensitivity:
Rapid Testing WHO/FDA/JpMHLW/ Specificity:
To detect surface not be attached by more than Country of
Kits must be for EU MDD (notifying more than
S NO. Name of Company Descrtiption antigen of HBV in sides. Pack Size of 98% in origin: USA,
In Vitro Human body) 98% in
whole blood. 100 or less along Whole Europe, Japan
diagnostics (IVD). approved/certified Whole Blood
with Blood.
buffer/reagents
1 ZEDCO Determine HBsAg , Alere, Japan YES YES YES YES YES YES YES
1 ZEDCO Determine HBsAg , Alere, Japan YES YES YES YES YES YES YES YES Responsive
HBsAg, Rapi Card Insta Test,Diagnostics YES (FDA only for YES (Duration not Non
YES NO NO YES YES YES
Automation/cortez Diagnostics..INC USA export) mentioned) Responsive
2 Greens Pharmacueticals
HCV Rapi Card Insta Test,Diagnostics YES (FDA only for YES (Duration not Non
YES NO NO YES YES YES
Automation/cortez Diagnostics..INC USA export) mentioned) Responsive
Onsite HBsAg Rapid Test, CTK BIOTECH, YES (FDA only for YES (Duration not Non
YES NO YES YES YES YES
USA export) mentioned) Responsive
Mian Scientific
3
Corporation pvt ltd
Onsite HCV Ab Plus Rapid Test, CTK YES (FDA only for YES (Duration not Non
YES No YES YES YES YES
Biotech, USA export) mentioned) Responsive