DIALINE HDL-Chol Direct Selective - Indonesia BPOM Medical Device Registration
DIALINE HDL-Chol Direct Selective is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101813151. 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
Cholesterol (total) test system (kit & cair)
Invitro Diagnostics
DIALINE LDL - CHOL
BIOMAJESTY Cholesterol FS
BIOMAJESTY Urea FS
BIOMAJESTY UIBC FS
PROLINE - b CK-MB FS
BIOMAJESTY Pancreatic Amylase CC FS
BIOMAJESTY LDL-C Select FS
BIOMAJESTY Cholinesterase FS
BIOMAJESTY Apolipoprotein A1 FS
DIALINE Creatinine Jaffe-Method
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 Bionorm Universal Control Serum
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE BioCAL Universal Calibrator
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE BioPath Universal Control Serum
DIALINE 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.

