VIDAS EBV VCA/EA IgG (VCAG) - Indonesia BPOM Medical Device Registration
VIDAS EBV VCA/EA IgG (VCAG) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420312. The device is manufactured by BIOMERIEUX SA from France, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
BIOMERIEUX SACountry of Origin
France
Authorized Representative
PT. ENSEVAL MEDIKA PRIMAAR Address
JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG
Registration Date
Jul 11, 2024
Expiry Date
Dec 31, 2026
Product Type
Serological Reagents
Epstein-Barr virus serological reagents.
Invitro Diagnostics
PREVI Color Gram Acetone Fuschin Solution - RA3
VIDAS Anti-HEV IgM (HEVM)
VIDAS Anti-HEV IgG (HEVG)
VIDAS Anti-DENGUE IgM (DENM)
LIVES Anti-DENGUE IgG (DENG)
LIVES DENGUE NS1 Ag (DEAG)
VIDAS EBV VCA IgM (VCAM)
VIDAS EBV EBNA IgG (EBNA)
BIOMERIEUX API NaCI 0,85% Medium
VIDAS Toxo IgG Avidity/ TXGA
MEDRAD Salient Contrast Injector Wireless
PLEXUS MANUFACTURING SDN. BHD. (HILLSIDE)
MEDRAD Salient Contrast Injector Non-Wireless
PLEXUS MANUFACTURING SDN. BHD. (HILLSIDE)
HOKAPI™ CUVETTE
SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD
DENSICHECK Plus Instrument for VITEK 2 System and Accessories
BIOMERIEUX INC.
VITEK MS System and Accessories
KRATOS ANALYTICAL LTD.
BIOMERIEUX Mycoline
AIDIAN
BIOMERIEUX Uriline
AIDIAN
BacT/ALERT VIRTUO Microbial Detection System and Accessories
BIOMERIEUX INC. (MISSOURI)
Bact/Alert 3D 240
BIOMERIEUX INC. (Missouri)
FILMARRAY Torch and accessories
BIOFIRE DIAGNOSTICS, LLC