Geenius™ HCV Supplemental Controls - Indonesia BPOM Medical Device Registration
Geenius™ HCV Supplemental Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305320674. The device is manufactured by BIO-RAD from France, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
BIO-RADCountry of Origin
France
Authorized Representative
PT. ANDAMAN MEDICAL INDONESIAAR Address
Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma
Registration Date
Jan 25, 2023
Expiry Date
Sep 01, 2025
Product Type
Immunological Test System
Antinuclear antibody immunological test system.
Invitro Diagnostics
Geenius HIV 1/2 Confirmatory Assay
Access HIV combo V2
Access HIV combo V2 Calibrators
Access HIV combo V2 QC
BIO-RAD Access HIV combo V2 QC plus
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MONOLISA HCV Ag-Ab ULTRA V2
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BIO-RAD IH-1000 and Accessories
Geenius™ HIV 1/2 Confirmatory Controls
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SONOVA AT
PHONAK TERRA+ BTE-M
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PHONAK TERRA+ BTE-UP
SONOVA AT