ABX Pentra Iron CP - Indonesia BPOM Medical Device Registration
ABX Pentra Iron CP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101817889. 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 HORIBA INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DIASYS DIAGNOSTIC SYSTEMS GMBH.Country of Origin
Germany
Authorized Representative
HORIBA INDONESIAAR Address
Jl. Jalur Sutera , Blok. 20A, No. 16 - 17, Kel. Kunciran, Kec. Pinang
Registration Date
Nov 25, 2022
Expiry Date
Oct 01, 2027
Product Type
Clinical Chemistry Test System
Iron-binding capacity test system (kit & cair)
Invitro Diagnostics
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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)
Yumizen C Urine Level 1 Control
DIASYS DIAGNOSTIC SYSTEMS GMBH
ABX PENTRA CRP HS CAL
DENKA SEIKEN CO.,LTD
Yumizen CR UREA/BUN (UV)
HORIBA INDIA PRIVATE LIMITED
Yumizen CR BILIRUBIN TOTAL
HORIBA INDIA PRIVATE LIMITED
Yumizen CR CHOLESTEROL
HORIBA INDIA PRIVATE LIMITED
Yumizen CR BILIRUBIN DIRECT
HORIBA INDIA PRIVATE LIMITED
Yumizen CR GPT (TOOL)
HORIBA INDIA PRIVATE LIMITED
Yumizen CR URIC ACID
HORIBA INDIA PRIVATE LIMITED
Yumizen CR TRIGLYCERIDES
HORIBA INDIA PRIVATE LIMITED
Yumizen CR Creatinine
HORIBA INDIA PRIVATE LIMITED