ALINITY c Digitoxin Reagent Kit - Indonesia BPOM Medical Device Registration
ALINITY c Digitoxin Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103320460. The device is manufactured by BIOKIT, S.A. from Spain, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
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
Jul 29, 2024
Expiry Date
May 14, 2029
Product Type
Clinical Toxicology Test System
Digitoxin test system (kit & cair)
Invitro Diagnostics
ALINITY c Digitoxin Standard
Quantia ฮฒ2-Microglobulin
Quantia ฮฒ2-Microglobulin Standard
Quantia PROTEINS Control
Quantia Ferritin Standard
QUANTIA RF Standard
ASO Standard AMOUNT
Standard IgE Amount
ALINITY c Ferritin/Myoglobin/IgE Control Kit
ALINITY c Myoglobin 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