IVD Cluster Autoimmune Diseases - Vietnam Registration 230001741/PCBB-HCM
Access comprehensive regulatory information for IVD Cluster Autoimmune Diseases 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 230001741/PCBB-HCM and manufactured by Theo theo phụ lục.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Monobind, Inc., DRG Instruments GmbH, and 2 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
230001741/PCBB-HCM
000.00.19.H29-230727-0025
Theo theo phụ lục
Theo phụ lục
Technical Details
- ANA SCREEN IgG is an enzyme-linked immunosorbent assay (ELISA) to detect IgG antibodies against ANA in human serum or plasma. - ENA Combined Screen is a qualitative screening test to detect antibodies against extractable nuclear antigens (ENA) in human serum. This test can detect all other ENA antibodies, such as Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. - ds-DNA is an enzyme-linked immunosorbent assay (ELISA) to detect IgG antibodies against double-stranded DNA in human serum or plasma. - RF IgM is used in the quantitative measurement of IgM RF in human serum.
Dates and Status
Aug 02, 2023