ARCHITECT Cyfra 21-1 Reagent Kit - Indonesia BPOM Medical Device Registration
ARCHITECT Cyfra 21-1 Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306111042. The device is manufactured by FUJIREBIO DIAGNOSTICS 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
FUJIREBIO DIAGNOSTICS 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
Sep 08, 2022
Expiry Date
Aug 09, 2027
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
ARCHITECT CA 19-9XR Reagent Kit
ALINITY i CA 125 II Controls
ARCHITECT Tacrolimus Whole Blood Precipitation Reagent
ARCHITECT Methotrexate Calibrators
ARCHITECT Methotrexate Extended Range Controls
ARCHITECT Methotrexate Controls
ARCHITECT HE4 Controls
ARCHITECT HE4 Reagent Kit
ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit
ALINITY i Methotrexate 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