IVD Marker for Rheumatoid Arthritis - Vietnam Registration 240000417/PCBB-HN
Access comprehensive regulatory information for IVD Marker for Rheumatoid Arthritis in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000417/PCBB-HN and manufactured by Boditech Med Inc.. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo theo phụ lục, Beckman Coulter, Inc., and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
240000417/PCBB-HN
000.00.19.H26-240223-0014
Theo theo phụ lục
Theo phụ lục
Technical Details
AFIAS Anti-CCP Plus is a fluorescent immunoassay (FIA) test to determine the presence or semi-quantify the human IgG autoantibodies against cyclic citrullinated peptides (CCP) in the whole blood/plasma/serum of the patient. It is very useful to support the diagnosis of rheumatoid arthritis (RA) in combination with clinical findings and other tests. It is intended for in vitro diagnostic use only. AFIAS CRP is a fluorescent immunoassay (FIA) test to determine the concentration of C-Reactive Protein (CRP) in the whole blood/plasma/serum of the patient. It is very useful to support the management and monitoring of autoimmune diseases and infectious processes, such as rheumatoid arthritis. It is intended for in vitro diagnostic use only. Boditech Anti-CCP Plus Control is designed to be used in in vitro diagnostic testing as a quality control measure for the Anti-CCP Plus Test. It is intended for in vitro diagnostic use only. Boditech CRP Control is designed to be used in in vitro diagnostic testing as a quality control measure for the CRP Assay Kit. It is intended for in vitro diagnostic use only. Boditech RF IgM Control is intended for in vitro diagnostic testing as a quality control measure for the RF IgM Assay Kit. It is intended for in vitro diagnostic use only. ichroma ™ Anti-CCP Plus is a fluorescent immunoassay (FIA) test to determine the presence or semi-quantify the human IgG autoantibodies against cyclic citrullinated peptides (CCP) in the whole blood/plasma/serum of the patient. It is very useful to support the diagnosis of rheumatoid arthritis (RA) in combination with clinical findings and other tests. It is intended for in vitro diagnostic use only. Ichroma™ ASO is a fluorescent immunoassay (FIA) test to determine the concentration of Anti Streptolysin O (ASO) in the plasma/serum of the patient. It is very useful as a supportive test in the management and monitoring of scarlet fever, rheumatoid fever and post-infectious glomerulonephritis, as well as in the management and monitoring of certain other conditions. It is intended for in vitro diagnostic use only. ichroma ™ CRP is a fluorescent immunoassay (FIA) test to determine the concentration of CRP in the whole blood/plasma/serum of the patient. It is very useful to support the management and monitoring of autoimmune diseases and infectious processes, such as rheumatoid arthritis. It is intended for in vitro diagnostic use only. ichroma™ hsCRP All in one is a fluorescent immunoassay test to determine the concentration of CRP in the whole blood/plasma/serum of the patient. It is very useful to support the diagnosis, treatment and monitoring of infections, tissue damage and inflammatory disorders. It is intended for in vitro diagnostic use only. ichroma™ RF IgM is a fluorescent immunoassay (FIA) test to determine the concentration of RF IgM in the whole blood/plasma/serum of the patient. It is very useful as a supportive test in the management and monitoring of rheumatoid arthritis. It is intended for in vitro diagnostic use only.
Dates and Status
Feb 29, 2024
IVD Marker for Rheumatoid Arthritis: CRP, ASO
Beckman Coulter, Inc.
240002764/PCBB-HN
IVD Marker for Rheumatoid Arthritis
Theo theo phụ lục
230002455/PCBB-HN
IVD Marker for Rheumatoid Arthritis: ASO, CRP, Rheumatod (RF)
Theo theo phụ lục
230002158/PCBB-HN
The IVD Marker for Rheumatoid Arthritis
Theo theo phụ lục
230000307/PCBB-HCM
IVD Marker for Rheumatoid Arthritis
Theo theo phụ lục
230000016/PCBB-BYT

