ALINITY i Anti-HBe Reagent Kit - Indonesia BPOM Medical Device Registration
ALINITY i Anti-HBe Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305124176. The device is manufactured by ABBOTT GMBH from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
ABBOTT GMBHCountry of Origin
Germany
Authorized Representative
ABBOTT PRODUCTS INDONESIAAR Address
Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA
Registration Date
May 09, 2024
Expiry Date
Jan 09, 2029
Product Type
Immunological Test System
Antimitochondrial 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 Controls
ARCHITECT Syphilis TP Calibrator
ARCHITECT Anti-HCV Reagent Kit
ALINITY i Syphilis TP Calibrator
ARCHITECT Anti-HCV Controls
ARCHITECT Estradiol Reagent Kit
ABBOTT IRELAND DIAGNOSTICS DIVISION.
ARMADA 35 PTA Catheter
ABBOTT VASCULAR COSTA RICA
ARCHITECT PIVKA-II Controls
DENKA CO., LTD.
ARCHITECT PIVKA-II Reagent Kit
DENKA CO., LTD.
ALINITY i PIVKA-II Controls
DENKA CO., LTD.
ALINITY i PIVKA-II Calibrators
DENKA CO., LTD.
XIENCE Xpedition 48 Everolimus Eluting Coronary Stent System
ABBOTT VASCULAR
ALINITY c Calcium2
ABBOTT IRELAND DIAGNOSTICS DIVISION
HI-TORQUE Command 18 LT Guide Wire
ABBOTT VASCULAR
ARCHITECT BNP Controls
FUJIREBIO DIAGNOSTICS, INC.