DIALINE CK-MB IFCC/DGKC - Indonesia BPOM Medical Device Registration
DIALINE CK-MB IFCC/DGKC is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101110873. The device is manufactured by DIASYS DIAGNOSTIC SYSTEMS GMBH. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DIATRON PROMEDIKA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DIASYS DIAGNOSTIC SYSTEMS GMBH.Country of Origin
Germany
Authorized Representative
PT. DIATRON PROMEDIKAAR Address
Perkantoran Plaza Pasifik Blok B2/41 Jl. Boulevard Barat Raya, Kelapa Gading
Registration Date
Feb 01, 2025
Expiry Date
Sep 25, 2029
Product Type
Clinical Chemistry Test System
Creatine phosphokinase/creatine kinase or isoenzymes test system(kit & cair)
Invitro Diagnostics
DIALINE BioCal HDL/LDL
DIALINE Alkaline Washing Solution
DIALINE Bionorm Universal Control Serum
DIALINE BioCAL Universal Calibrator
DIALINE Lipase Direct Colorimetric
DIALINE CK-NAC IFCC/DGKC
YUMIZEN C Urine Level 2 Control
DIALINE Cholesterol CHOD-PAP
DIALINE ALAT/ALT (GPT)
DIALINE Creatinine Enzymatic - PAP
DIALINE Triglycerides GPO - PAP
DIASYS DIAGNOSTIC SYSTEM GMBH.
DIALINE Bionorm L
DIASYS DAIGNOSTIC SYSTEMS GMBH.
DIALINE BioCal HDL/LDL
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE HbA1c
DIASYS DIAGNOSTIC SYSTEM, GMBH
DIALINE BioCal HbA1c
DIASYS DIAGNOSTIC SYSTEM GMBH.
DIALINE Bionorm Universal Control Serum
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE BioCAL Universal Calibrator
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE HDL-Chol Direct Selective
DIASYS DIAGNOSTIC SYSTEMS, GMBH.
DIALINE Magnesium
DIASYS DAIGNOSTIC SYSTEMS GMBH.
DIALINE BioPath Universal Control Serum
DIALINE DIAGNOSTIC SYSTEMS GMBH.