COBAS MAI Positive control kit - Indonesia BPOM Medical Device Registration
COBAS MAI Positive control kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321172. The device is manufactured by ROCHE MOLECULAR SYSTEM, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ROCHE 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 : 2
Manufacturer
ROCHE MOLECULAR SYSTEM, INC.Country of Origin
United States
Authorized Representative
PT. ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Jun 01, 2023
Expiry Date
Jan 24, 2028
Product Type
Serological Reagents
Nucleic acid-based in vitro diagnostics devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens (kit & cair)
Invitro Diagnostics
COBAS MTB
COBAS TV/MG
COBAS TV/MG Positive Control Kit
COBAS MPX Multiplex HIV, HCV & HBV nucleic acid test for use on the cobas 6800/8800 Systems
COBAS MPX Control Kit Positive Control Kit for Use on The Cobas 6800/8800 Systems
COBAS PreciControl CMV IgG Avidity Elecsys and cobas e analyzers
ROCHE DIAGNOSTICS GMBH.
COBAS MPXV
ROCHE MOLECULAR SYSTEMS, INC.
COBAS CREP2 Creatinine Plus ver.2 COBAS INTEGRA / cobas c systems
ROCHE DIAGNOSTICS GMBH.
COAGUCHEK PT Test
ROCHE DIAGNOSTICS GMBH.
COBAS S2 Fluid Pack
ROCHE DIAGNOSTICS INTERNATIONAL, LTD.
ROCHE Cardiac POC Troponin T 2-Level Control
ROCHE DIAGNOSTICS GMBH
COBAS Elecsys CA 15-3 ll Elecsys and cobas e analyzer
ROCHE DIAGNOSTICS GMBH.
COBAS u 601 Urine Analyzer and Accessories
77 ELECTRONICS INSTRUMENT INDUSTRY LTD.
ISE Reference Electrolyte Roche / Hitachi cobas c
ROCHE DIAGNOSTICS GMBH.
COBAS Insulin CalSet Elecsys and cobas e analyzers
ROCHE DIAGNOSTICS GMBH.