BIO SB Hepatocyte Specific Antigen / Hep-Par 1 (OCH1E5), MMab - Indonesia BPOM Medical Device Registration
BIO SB Hepatocyte Specific Antigen / Hep-Par 1 (OCH1E5), MMab is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10201420094. The device is manufactured by BIO SB, INC from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is BIOSAINS MEDIKA INDONESIA.
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 : 1
Manufacturer
BIO SB, INCCountry of Origin
United States
Authorized Representative
BIOSAINS MEDIKA INDONESIAAR Address
PLAZA KARINDA BLOK B1/4, JALAN KARANG TENGAH RAYA
Registration Date
Jun 10, 2024
Expiry Date
Aug 24, 2026
Product Type
Biological Dyes
Immunohistochemistry reagents and kits (Qualitative).
Invitro Diagnostics
BIO SB CD5 (RBT-CD5), RMab
BIO SB Melanosome HMB45, HMB-45, MMab
BIO SB Vimentin (V9), MMab
BIO SB HER-2 neu (RBT-HER2), RMab
BIO SB CD20 (L26), MMab
BIO SB Synaptophysin (EP158), RMab
Bio SB Alk-1/CD246, EP302, RMB
BIO SB Helicobacter Pylori (Polyclonal), RPab
Bio SB Ki-67 (EP5), RMB
BIO SB Cytokeratin 20 (Ks20.8), MMab
BIO SB Vimentin (V9), MMab
BIO SB, INC
BIO SB CD20 (L26), MMab
BIO SB, INC
BIO SB Synaptophysin (EP158), RMab
BIO SB, INC
Bio SB Ki-67 (EP5), RMB
BIO SB, INC
BIO SB Helicobacter Pylori (Polyclonal), RPab
BIO SB, INC
BIO SB Cytokeratin 20 (Ks20.8), MMab
BIO SB, INC
BIO SB HPV16 (CAMVIR-1), MMab
BIO SB, INC
BIO SB PAX-2 (EP235), RMab
BIO SB, INC
BIO SB Tinto p120 Catenin (EP66), RMab
BIO SB, INC
BIO SB p16 (16P04, JC02), MMab
BIO SB, INC

