ALINITY i PIVKA-II Reagent Kit - Indonesia BPOM Medical Device Registration
ALINITY i PIVKA-II Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306420233. The device is manufactured by DENKA CO., LTD. from Japan, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DENKA CO., LTD.Country of Origin
Japan
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA
Registration Date
Nov 14, 2024
Expiry Date
Jul 12, 2029
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
ARCHITECT HCV Ag Reagent Kit
ARCHITECT PIVKA-II Reagent Kit
ARCHITECT PIVKA-II Calibrators
ARCHITECT PIVKA-II Controls
ALINITY i PIVKA-II Controls
ALINITY i PIVKA-II Calibrators
BECKMAN COULTER Myoglobin
ALINITY i SCC Controls
ALINITY i SCC Reagent Kit
ARCHITECT SCC Reagent Kit
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