CDSCO UID MFG/IVD/2020/000118_8614dd2d7c953609a9d12561a3446705_0249a3f92c6b3fdf9a4abc36b4f24105
One Step Test for HBsAg
ORCHID BIOMEDICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED·Device Class Class D·India CDSCO·Brand: Device
Registration details
- UID
- MFG/IVD/2020/000118_8614dd2d7c953609a9d12561a3446705_0249a3f92c6b3fdf9a4abc36b4f24105
- Device class
- Class D
- Brand name
- Device
- Approving authority
- Sub Zonal Goa
- Product information
- Rapid Qualitative Two Site Sandwich Immunassay for the detection of Hepatitis B Surface Antigen , a marker of Hepatitis B infections serum / plasma specimen
Similar products (10)
Other products with the same name or brand
One Step Test for HBsAg
Brand: Gargle based
Meril Diagnostics Pvt. Ltd.
Class D
Rapid Immunoconcentration Assay for detection of Antibodies to HIV 1 & 2 and HCV in Human Serum/Plasma ;
Brand: Device
QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Class D
Third Generation Double Antigen Sandwich Enzyme Linked Immunosorbent Assay for detection of antibodies to Treponema Pallidum in human serum or plasma
Brand: Device
QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Class D
Enzyme Linked Immunosorbent Assay for detection of Hepatitis B Surface Antigen in human serum or plasma
Brand: Device
QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Class D
Enzyme Linked Immunosorbent Assay for detection of Hepatitis B Surface Antigen in human serum or plasma
Brand: Device
QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Class D
Rapid Immunochromatography Test for HCV (FLAVICHECK HCV WB )
Brand: Device
QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Class D
Rapid Immunochromatography Test For HIV 1 and HIV 2 (RETROSCREEN HIV )
Brand: Device
QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Class D
Enzyme Linked Immunosorbent Assay for detection of antibodies to HIV 1 and 2 in human serum or plasma
Brand: Device
QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Class D
Enzyme Linked Immunosorbent Assay for detection of antibodies to HCV in human serum or plasma
Brand: Device
QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Class D
Rapid Immunochromatography Test for HIV 1 and HIV 2 (Device(QUALPRO HIV )
Brand: Device
QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Class D
Other products from ORCHID BIOMEDICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Products from the same license holder (10 products)
RAPID TEST FOR P. FALCIPARUM MALARIA
Brand: PARACHECK PF DEVICE
Class C
RAPID TEST FOR P. FALCIPARUM MALARIA
Brand: PARACHECK PF DEVICE
Class C
One Step Test for HBsAg
Brand: Device
Class D
Rapid Double Antigen Screening test for the detection of IgM / IgG / IgA antibodies to COVID-19 in human serum/ plasma/ whole blood
Brand: Device
Class D
One Step Test for HBsAg (VIRUCHECK HBsAg )
Brand: Device
Class D
Rapid Immunochromatographic Assay for detection of IgM antibodies to HAV in human serum/plasma(INSIGHT HAV IgM )
Brand: DEVICE
Class B
One Step Pregnancy Test (TINA hCG )
Brand: DEVICE
Class B
One Step Pregnancy Test
Brand: DEVICE
Class B
One Step Pregnancy Test
Brand: DEVICE
Class B
Rapid Immunochromatographic Assay for detection of IgM antibodies to HEV in human serum/plasma(INSIGHT HEV IgM )
Brand: DEVICE
Class B
About this record
One Step Test for HBsAg is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000118_8614dd2d7c953609a9d12561a3446705_0249a3f92c6b3fdf9a4abc36b4f24105. This device is marketed under the brand name Device. The license holder is ORCHID BIOMEDICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Goa.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.