AQUIOS Lysing Reagent Kit - Indonesia BPOM Medical Device Registration
AQUIOS Lysing Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208320510. The device is manufactured by CLINICAL DIAGNOSTIC SOLUTIONS, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FOCUS DIAGNOSTIC 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
CLINICAL DIAGNOSTIC SOLUTIONS, INC.Country of Origin
United States
Authorized Representative
PT. FOCUS DIAGNOSTIC INDONESIAAR Address
Jl. Jatipadang Raya No.9A, RT.6/RW.4, Kelurahan Jatipadang, Kecamatan Pasar Minggu, Kota Jakarta Selatan, DKI Jakarta 12540
Registration Date
Mar 30, 2023
Expiry Date
Jun 01, 2025
Product Type
Hematological Reagents
Red cell lysing reagent.
Invitro Diagnostics
FOKUS FDI HM-3 Plus Diluent Hematology Reagent
AEHEALTH LIMITED
FlowClean Cleaning Agent
BECKMAN COULTER, INC.
FOKUS Auto 3-Diff Hematology Analyzer
AEHEALTH LIMITED
AQUIOS Cleaning Agent
BECKMAN COULTER, INC.
FOKUS FDI HM-5 Plus DIFF Lyse Hematology Reagent
AEHEALTH LIMITED
FOCUS Leptospira IgM Cassette
ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.
FOKUS FDI HM-5 Plus Diluent Hematology Reagent
AEHEALTH LIMITED
FOCUS Syphicheck WB device
ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.
FOKUS Love-Gruenwald Laminectomy Rongeur Instrument
CEATEC MEDIZINTECHNIK GMBH & CO. KG.
FOKUS Measuring Instrument Set II
CEATEC MEDIZINTECHNIK GMBH

