Access HIV combo V2 - Indonesia BPOM Medical Device Registration
Access HIV combo V2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305321205. The device is manufactured by BIO-RAD from France, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. DHH TRADING INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
BIO-RADCountry of Origin
France
Authorized Representative
PT. DHH TRADING INDONESIAAR Address
Gedung World Trade Center 3, Lt. 20, Jl. Jend. Sudirman Kav. 29-31, Kel. Karet, Kec. Setiabudi, Jakarta Selatan, DKI Jakarta
Registration Date
Nov 04, 2023
Expiry Date
Feb 10, 2026
Product Type
Immunological Test System
Multiple autoantibodies immunological test system.
Invitro Diagnostics
Geenius HIV 1/2 Confirmatory Assay
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™ HIV 1/2 Confirmatory Controls
Geenius™ HCV Supplemental Controls
BIO-RAD IH-1000 and Accessories
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