BIOCARE Combo 4 (HBsAg, HCV, HIV, Syphilis) Rapid Test Device - Indonesia BPOM Medical Device Registration
BIOCARE Combo 4 (HBsAg, HCV, HIV, Syphilis) Rapid Test Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305124662. The device is manufactured by ASSURE TECH (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. PROSPEROUS BIOCARE.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
ASSURE TECH (HANGZHOU) CO., LTD.Country of Origin
China
Authorized Representative
PT. PROSPEROUS BIOCAREAR Address
Ruko Kranggan Permai Blok RT 17 No. 30 Jatisampurna, Bekasi, Jawa Barat 17433
Registration Date
Jun 19, 2024
Expiry Date
Sep 18, 2025
Product Type
Immunological Test System
Multiple autoantibodies immunological test system.
Invitro Diagnostics
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DrAccu Free Thyroxine (FT4) FIA
DrAccu NT-ProBNP FIA
DrAccu FSH FIA
DrAccu CEA FIA
DrAccu PCT FIA
ASSURE TECH (HANGZHOU) CO., LTD.
DrAccu ฮฒ-HCG FIA
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DrAccu Micro-Albumin FIA
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DrAccu AFP FIA
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REALBEST DNA HPV HR Screen (Set 1)
TO VECTOR-BEST
DrAccu Prolactin FIA (Whole Blood/Pasma/Serum)
ASSURE TECH (HANGZHOU) CO., LTD.
RealBest HBV/HCV/HIV PCR
TO VECTOR-BEST
DrAccu Free Triiodothyronine (FT3) FIA
ASSURE TECH (HANGZHOU) CO., LTD.
DrAccu Progestin FIA
ASSURE TECH (HANGZHOU) CO., LTD.
DrAccu E2 FIA
ASSURE TECH (HANGZHOU) CO. LTD.

