COBAS BNZ2 - Indonesia BPOM Medical Device Registration
COBAS BNZ2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103320485. The device is manufactured by ROCHE DIAGNOSTICS GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ROCHE INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ROCHE DIAGNOSTICS GMBHCountry of Origin
Germany
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Aug 02, 2023
Expiry Date
May 22, 2028
Product Type
Clinical Toxicology Test System
Benzodiazepine test system (kit & cair)
Invitro Diagnostics
ROCHE Cardiac POC Troponin T 2-Level Control
PreciControl Maternal Care
ELECSYS proBNP II cobas e analyzers
ELECSYS Troponin T hs cobas e analyzers
COBAS Elecsys PTH
Elecsys FSH cobas e analyzers
Elecsys CA 72-4 cobas e analyzers
ABX Pentra P MultiControl
ELECSYS HBsAg Confirmatory Test
BECKMAN COULTER HbA1c Advanced
Elecsys Anti-SARS-CoV-2 cobas e analyzers
ROCHE DIAGNOSTICS GMBH.
PreciControl Maternal Care
ROCHE DIAGNOSTICS GMBH
COAGUCHEK aPTT Test
ROCHE DIAGNOSTICS GMBH.
ROCHE TROP T Sensitive, Troponin T
ROCHE DIAGNOSTICS GMBH.
COBAS BM - Lactate
ROCHE DIAGNOSTICS GMBH.
ultraView Universal Alkaline Phosphatase Red Detection Kit
VENTANA MEDICAL SYSTEMS, INC.
COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Wash Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Lysis Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Specimen Diluent
ROCHE MOLECULAR SYSTEMS INC.