ALINITY c β2-Microglobulin Standard - Indonesia BPOM Medical Device Registration
ALINITY c β2-Microglobulin Standard is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305913700. 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.
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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
Jun 14, 2019
Expiry Date
Apr 01, 2024
Product Type
Immunological Test System
Beta -2-microglobulin immunological test system.
Invitro Diagnostics
ALINITY c Digitoxin Reagent Kit
ALINITY c Digitoxin Standard
Quantia β2-Microglobulin
Quantia β2-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 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

