ALINITY c D-Dimer - Indonesia BPOM Medical Device Registration
ALINITY c D-Dimer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207320333. The device is manufactured by BIOKIT S.A. from Spain, 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
BIOKIT S.A.Country of Origin
Spain
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA
Registration Date
Dec 23, 2024
Expiry Date
Aug 27, 2029
Product Type
Haematology Package and Kit
Fibrinogen/fibrin degradation products assay.
Invitro Diagnostics
ALINITY c D-Dimer Controls
ALINITY c D-Dimer Calibrator
ALINITY c Digitoxin Controls
BECKMAN COULTER ASO
QUANTIA D-Dimer Standard
ARCHITECT iDigoxin Calibrators
AMOUNT D-Dimer
AMOUNT ASO-RF Control I
ARCHITECT SHBG Reagent Kit
ARCHITECT DHEA-S 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