ACCU-TELL COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) - Indonesia BPOM Medical Device Registration
ACCU-TELL COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303025890. The device is manufactured by ACCUBIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ISOTEKINDO INTERTAMA.
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
ACCUBIOTECH CO., LTD.Country of Origin
China
Authorized Representative
ISOTEKINDO INTERTAMAAR Address
Jl. Raya Kebayoran Lama No. 309 C Jakarta 12210
Registration Date
Aug 25, 2021
Expiry Date
May 28, 2025
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
ACCU-TELL Dengue IgG,IgM,NS1 Combo Cassette (Whole Blood/Serum/Plasma)
ACCU-TELL Malaria P.f/P.v/Pan Cassette (Whole Blood)
BERDIA Multi-7 Drug Panel AMP500/BZO300/COC300/MET500/MOP300/THC50/CAR1000
BERDIA Multi-7 Drug Panel AMP500/BZO300/COC300/MET500/MOP300/THC50/K2-30
ACCU-TELL Multi-10 Drug Test (Urine)(AMP500/MET500/BZO300/ THC50/MOP300/COC300/CAR1000 /K2 30/MDMA500/MTD300)
ACCU-TELL Typhoid Cassette (Whole Blood/Serum/Plasma)
ACCU-TELL Multi 7 Drug Panel (Urine)
BERDIA Multi-8 Drug Panel (AMP500/BZO300/COC300/THC50/ OPI2000/MET500/MDMA500/MOP300)
ACCU-TELL Chikungunya IgG/IgM Cassette (Whole Blood/Serum/Plasma)
ACCU-TELL TB Cassette (Whole Blood/Serum/Plasma)
BEACON Widal Positive Control
BEACON DIAGNOSTIC PVT., LTD
BEACON Widal Negative Control
BEACON DIAGNOSTIC PVT., LTD
HemoSmart GOLD Hemoglobin Control Solution
APEX BIOTECHNOLOGY CORP.
UASURE II Uric Acid Control Solution
APEX BIOTECHNOLOGY CORP.
BEACON Stained Salmonella Antigen S. Paratyphi 'CH' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
BEACON Stained Salmonella Antigen S. Paratyphi 'BH' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
BEACON Stained Salmonella Antigen S. Paratyphi 'AH' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
BEACON Stained Salmonella Antigen S. Paratyphi 'CO' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
BEACON Stained Salmonella Antigen S. Paratyphi 'BO' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
BEACON Stained Salmonella Antigen S. Paratyphi 'AO' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD