ABBOTT Alinity m EBV AMP Kit - Indonesia BPOM Medical Device Registration
ABBOTT Alinity m EBV AMP Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321461. The device is manufactured by ABBOTT MOLECULAR, INC. from United States, and is classified as Risk Class Kelas Resiko : C. 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
ABBOTT MOLECULAR, INC.Country of Origin
United States
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Oct 09, 2023
Expiry Date
Jan 21, 2027
Product Type
Serological Reagents
Epstein-Barr virus serological reagents.
Invitro Diagnostics
ABBOTT Alinity m EBV CTRL Kit
ALINITY m Resp-4-Plex CTRL Kit
ABBOTT Alinity m Resp-4-Plex AMP Kit
ABBOTT Alinity m SARS-CoV-2 AMP Kit
ABBOTT REALTIME HIV-1 Calibrator Kit
Abbott Alinity m STI CTRL Kit
Abbott Alinity m HIV-1 AMP Kit
Abbott Alinity m STI AMP Kit
ABBOTT Alinity m SARS-CoV-2 CTRL Kit
Abbott Alinity m HR HPV AMP 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