ALINITY i HIV Ag/Ab Combo Calibrator - Indonesia BPOM Medical Device Registration
ALINITY i HIV Ag/Ab Combo Calibrator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305715101. The device is manufactured by ABBOTT GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
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
Jun 07, 2024
Expiry Date
Jan 09, 2029
Product Type
Immunological Test System
Multiple autoantibodies 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 Controls
ARCHITECT Syphilis TP Calibrator
ARCHITECT Anti-HCV Reagent Kit
ALINITY i Syphilis TP Calibrator
ARCHITECT Anti-HCV Controls
ALINITY c Lactate Dehydrogenase2
ABBOTT IRELAND DIAGNOSTICS DIVISION
ARCHITECT Total T4 Reagent Kit
ABBOTT IRELAND DIAGNOSTICS DIVISION.
ALINITY c Amylase2
ABBOTT IRELAND DIAGNOSTICS DIVISION
ARCHITECT Consolidated Chemistry Calibrator
RANDOX LABORATORIES, LTD
ARCHITECT Total T4 Controls
ABBOTT IRELAND DIAGNOSTICS DIVISION.
MITRACLIP G4 NTW Clip Delivery System
ABBOTT MEDICAL (MENLO PARK)
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