LightCycler PRO 384 System - Indonesia BPOM Medical Device Registration
LightCycler PRO 384 System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304420018. The device is manufactured by ROCHE DIAGNOSTICS INTERNATIONAL LTD. from Switzerland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ROCHE INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ROCHE DIAGNOSTICS INTERNATIONAL LTD.Country of Origin
Switzerland
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Feb 28, 2024
Expiry Date
Dec 12, 2028
Product Type
Immunology Laboratory Equipment and Reagents
RNA Preanalytical Systems.
Invitro Diagnostics
ELECSYS GAAD
COBAS 6800 Systems
COBAS u 411 and Accessories
LightCycler PRO 96 System
Cobas b 123 (2) POC System
COBAS b 123 (4) POC System
MAGNA Pure 24 Instrument and Accessories
COBAS 6800 Systems
MagNA Pure 24 Instrument and Accessories
COBAS S3 Fluid Pack A
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.