ARCHITECT rHTLV-I/II Reagent - Indonesia BPOM Medical Device Registration
ARCHITECT rHTLV-I/II Reagent is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305810763. 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
Mar 28, 2023
Expiry Date
Jan 16, 2028
Product Type
Immunological Test System
Antinuclear antibody immunological test system.
Invitro Diagnostics
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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
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ARCHITECT Consolidated Chemistry Calibrator
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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
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CELL-DYN Emerald 22 Diluent
AVANTOR PERFORMANCE MATERIALS S.A.
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SANMINA-SCI SYSTEMS SINGAPORE PTE LTD