AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit - Indonesia BPOM Medical Device Registration
AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320222. The device is manufactured by AMOY DIAGNOSTICS CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is MAIN SYNERGY PROSPEROUS.
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
AMOY DIAGNOSTICS CO., LTD.Country of Origin
China
Authorized Representative
MAIN SYNERGY PROSPEROUSAR Address
Gedung Menara Salemba Lt.3, Jl. Salemba Raya No.5-5A
Registration Date
May 08, 2023
Expiry Date
Dec 15, 2027
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
AmoyDx® EML4-ALK Fusion Gene Detection Kit
AmoyDx® KRAS/NRAS Mutations Detection Kit
AmoyDx® Circulating DNA Kit
AmoyDx® Blood/Bone Marrow DNA Kit
AmoyDx® Tissue DNA Kit
AmoyDx® Tissue RNA Kit
AmoyDx® FFPE DNA/RNA Kit
AmoyDx® FFPE RNA Kit
AmoyDx® FFPE DNA Kit
AmoyDx® EGFR 29 Mutations Detection Kit
ABBOTT m2000rt Instruments and Accessories
ABBOTT MOLECULAR INC.
ABBOTT RealTime HBV Amplification Reagent Kit
ABBOT MOLECULAR INC.
ABBOTT RealTime HCV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
ABBOTT RealTime High Risk HPV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
ABBOTT RealTime HBV Control Kit
ABBOTT MOLECULAR INC.
AmoyDx® FFPE DNA/RNA Kit
AMOY DIAGNOSTICS CO., LTD.
AmoyDx® FFPE RNA Kit
AMOY DIAGNOSTICS CO., LTD.
ABBOTT RealTime HCV Control Kit
ABBOTT MOLECULAR INC.
ABBOTT REALTIME CT/NG Amplification Reagent Kit
ABBOT MOLECULAR INC.
ABBOTT REALTIME CT/NG Control Kit
ABBOT MOLECULAR INC