DIALINE HbA1c - Indonesia BPOM Medical Device Registration
DIALINE HbA1c is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101124188. The device is manufactured by DIASYS DIAGNOSTIC SYSTEM, 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 SYSTEM, GMBHCountry of Origin
Germany
Authorized Representative
PT. DIATRON PROMEDIKAAR Address
Perkantoran Plaza Pasifik Blok B2/41 Jl. Boulevard Barat Raya, Kelapa Gading
Registration Date
Feb 08, 2025
Expiry Date
Sep 25, 2029
Product Type
Clinical Chemistry Test System
Hemoglobin A1c test system.
Invitro Diagnostics
DIALINE UIBC
DSI Phosphate FS
DIALINE Iron (Fe)
DSI HDL-c direct FS
DSI LDH 21 FS
DSI URIC ACID STANDARD FS
DSI UREA STANDARD FS
DSI ALBUMIN STANDARD FS
DSI CHOLESTEROL STANDARD FS
DSI TOTAL PROTEIN STANDARD FS
DIALINE Bionorm L
DIASYS DAIGNOSTIC SYSTEMS GMBH.
DIALINE BioCal HDL/LDL
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE Triglycerides GPO - PAP
DIASYS DIAGNOSTIC SYSTEM GMBH.
DIALINE BioPath Universal Control Serum
DIALINE DIAGNOSTIC SYSTEMS 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 BioCal HbA1c
DIASYS DIAGNOSTIC SYSTEM GMBH.
DIALINE Uric Acid Uricase - TBHBA
DIASYS DIAGNOSTIC SYSTEM GMBH.