DIALINE Bionorm Universal Control Serum - Indonesia BPOM Medical Device Registration
DIALINE Bionorm Universal Control Serum is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101026639. 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 07, 2025
Expiry Date
Sep 25, 2029
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
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DIALINE Alkaline Washing Solution
DIALINE BioCAL Universal Calibrator
DIALINE Lipase Direct Colorimetric
DIALINE CK-NAC IFCC/DGKC
DIALINE CK-MB IFCC/DGKC
YUMIZEN C Urine Level 2 Control
DIALINE Cholesterol CHOD-PAP
DIALINE ALAT/ALT (GPT)
DIALINE Creatinine Enzymatic - PAP
DIALINE BioCal HDL/LDL
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE Bionorm L
DIASYS DAIGNOSTIC SYSTEMS GMBH.
DIALINE Triglycerides GPO - PAP
DIASYS DIAGNOSTIC SYSTEM GMBH.
DIALINE HbA1c
DIASYS DIAGNOSTIC SYSTEM, GMBH
DIALINE BioCal HbA1c
DIASYS DIAGNOSTIC SYSTEM GMBH.
DIALINE BioCAL Universal Calibrator
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE BioPath Universal Control Serum
DIALINE DIAGNOSTIC SYSTEMS GMBH.
DIALINE HDL-Chol Direct Selective
DIASYS DIAGNOSTIC SYSTEMS, GMBH.
DIALINE Magnesium
DIASYS DAIGNOSTIC SYSTEMS GMBH.
DIALINE Uric Acid Uricase - TBHBA
DIASYS DIAGNOSTIC SYSTEM GMBH.