ABX Pentra ALP CP - Indonesia BPOM Medical Device Registration
ABX Pentra ALP CP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101817611. 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. HORIBA INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DIASYS DIAGNOSTIC SYSTEMS GMBH.Country of Origin
Germany
Authorized Representative
PT. HORIBA INDONESIAAR Address
Jl. Jalur Sutera , Blok. 20A, No. 16 - 17, Kel. Kunciran, Kec. Pinang
Registration Date
Nov 09, 2022
Expiry Date
Sep 23, 2027
Product Type
Clinical Chemistry Test System
Alkaline phosphatase 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-MB IFCC/DGKC
DIALINE CK-NAC IFCC/DGKC
YUMIZEN C Urine Level 2 Control
DIALINE Cholesterol CHOD-PAP
DIALINE ALAT/ALT (GPT)
HORIBA Pentra C400 Option ISE and Accessories
HORIBA ABX SAS, FRANCE
ABX Pentra Standard 1
HORIBA ABX SAS, FRANCE
ABX Pentra Reference 280 ml
HORIBA ABX SAS, FRANCE
ABX Pentra Etching CP
HORIBA ABX SAS, FRANCE
ABX Pentra ISE Cleaner CP
HORIBA ABX SAS, FRANCE
ABX Pentra LDH IFCC CP
HORIBA ABX SAS, FRANCE
YUMIZEN C Urine Level 2 Control
DIASYS DIAGNOSTIC SYSTEMS GMBH.
HORIBA Pentra C400 and Accessories
HORIBA ABX SAS.
YUMIZEN G CTRL DDi I & II
DIAGON LTD
Yumizen G APTT 4
DIAGON LTD