ARCHITECT Anti-HCV Reagent Kit - Indonesia BPOM Medical Device Registration
ARCHITECT Anti-HCV Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305021091. The device is manufactured by ABBOTT GMBH from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
ABBOTT GMBHCountry of Origin
Germany
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA
Registration Date
Jul 04, 2024
Expiry Date
Jan 09, 2029
Product Type
Immunological Test System
Antinuclear antibody immunological test system.
Invitro Diagnostics
ALINITY i Anti-HBc IgM Controls
ALINITY i Anti-HBc IgM Reagent Kit
ALINITY i HBeAg Quantitative Calibrators
ALINITY i Syphilis TP Reagent Kit
ALINITY i HBeAg Quantitative Controls
ARCHITECT Syphilis TP Calibrator
ARCHITECT Syphilis TP Controls
ALINITY i Syphilis TP Calibrator
ARCHITECT Anti-HCV Controls
ARCHITECT Anti-HCV Calibrator
ALINITY c Lactate Dehydrogenase2
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ARCHITECT Total T4 Reagent Kit
ABBOTT IRELAND DIAGNOSTICS DIVISION.
ALINITY c Amylase2
ABBOTT IRELAND DIAGNOSTICS DIVISION
ARCHITECT Consolidated Chemistry Calibrator
RANDOX LABORATORIES, LTD
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MITRACLIP G4 NTW Clip Delivery System
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ABBOTT Amylase2
ABBOTT IRELAND DIAGNOSTICS DIVISION.
MITRACLIP G4 Steerable Guide Catheter
ABBOTT MEDICAL. (Menlo park)
CELL-DYN Emerald 22 Diluent
AVANTOR PERFORMANCE MATERIALS S.A.
ALINITY hs Slide Maker Stainer Module and Accessories
SANMINA-SCI SYSTEMS SINGAPORE PTE LTD

