cobas HPV Positive Control for use on the cobas 6800/8800 Systems - Indonesia BPOM Medical Device Registration
cobas HPV Positive Control for use on the cobas 6800/8800 Systems is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306127227. The device is manufactured by ROCHE MOLECULAR SYSTEMS from United States, 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 MOLECULAR SYSTEMSCountry 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
Nov 23, 2021
Expiry Date
Apr 13, 2026
Product Type
Tumor Antigen Immunologic Test System
Dna Detection for Human Papillomavirus
Invitro Diagnostics
COBAS SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
COBAS PIK3CA Mutation Test (PIK3CA)
COBAS MTB Positive Control Kit for use on the cobas 6800/8800 Systems
COBAS MTB Nucleic acid test for use on the cobas 6800/8800 Systems
cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat Systems
COBAS HBV
COBAS HPV Qualitative nucleic acid test for use on the cobas 6800/8800 systems
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COAGUCHEK aPTT Test
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COBAS BM - Lactate
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ultraView Universal Alkaline Phosphatase Red Detection Kit
VENTANA MEDICAL SYSTEMS, INC.
COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems
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COBAS omni Wash Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Lysis Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Specimen Diluent
ROCHE MOLECULAR SYSTEMS INC.

