COBAS omni Lysis Reagent - Indonesia BPOM Medical Device Registration
COBAS omni Lysis Reagent is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208023865. The device is manufactured by ROCHE MOLECULAR SYSTEMS INC. from United States, 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 MOLECULAR SYSTEMS INC.Country of Origin
United States
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Oct 31, 2024
Expiry Date
Jul 16, 2029
Product Type
Hematological Reagents
Red cell lysing reagent.
Invitro Diagnostics
COBAS DNA Sample Preparation Kit (DNA SP)
COBAS 4800 BRAF V600 Mutation Test
COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems
COBAS omni Wash Reagent
COBAS omni MGP Reagent
COBAS omni Specimen Diluent
COBAS 4800 System Wash Buffer Kit
COBAS 4800 System Liquid Cytology Preparation Kit
COBAS 4800 MRSA/SA Controls and Cofactor Kit (c4800 MRSA/SA CTLS/COFR)
COBAS 4800 MRSA/SA Amplification/Detection Kit (c4800 MRSA/SA AMP/DET)
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 Specimen Diluent
ROCHE MOLECULAR SYSTEMS INC.
Elecsys T3
ROCHE DIAGNOSTICS (SUZHOU) LTD