Geenius HIV 1/2 Confirmatory Assay - Indonesia BPOM Medical Device Registration
Geenius HIV 1/2 Confirmatory Assay is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305420575. The device is manufactured by BIO-RAD from France, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is ANDAMAN MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
BIO-RADCountry of Origin
France
Authorized Representative
ANDAMAN MEDICAL INDONESIAAR Address
Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma
Registration Date
Nov 20, 2024
Expiry Date
Aug 13, 2029
Product Type
Immunological Test System
Multiple autoantibodies immunological test system.
Invitro Diagnostics
Access HIV combo V2
Access HIV combo V2 Calibrators
Access HIV combo V2 QC
BIO-RAD Access HIV combo V2 QC plus
MONOLISA HBs Ag ULTRA
MONOLISA HCV Ag-Ab ULTRA V2
GEENIUS™ Reader and Accessories
Geenius™ HCV Supplemental Controls
BIO-RAD IH-1000 and Accessories
Geenius™ HIV 1/2 Confirmatory Controls
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