COBAS 4800 System Sample Preparation Kit 2 (c4800 SMPL PREP 2) - Indonesia BPOM Medical Device Registration
COBAS 4800 System Sample Preparation Kit 2 (c4800 SMPL PREP 2) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204712666. The device is manufactured by ROCHE MOLECULAR SYSTEMS, INC. from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is ROCHE INDONESIA.
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Risk Classification
Product Class
Kelas : 1
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
Jun 21, 2021
Expiry Date
Apr 15, 2026
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
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COBAS KRAS Mutation Test
COBAS Strep A Nucleic acid test for use on the cobas Liat System
COBAS Cdiff Nucleic acid test for use on the cobas Liat System
COBAS Strep A Quality Control Kit for use on the cobas Liat System
COBAS MPX
COBAS MPX - 480
COBAS® MPX Control Kit
COBAS Specimen Pre-Extraction Reagent
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.