ABX Pentra Ig M CP - Indonesia BPOM Medical Device Registration
ABX Pentra Ig M CP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305024459. 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 GMBHCountry of Origin
Germany
Authorized Representative
HORIBA INDONESIAAR Address
Jl. Jalur Sutera , Blok. 20A, No. 16 - 17, Kel. Kunciran, Kec. Pinang
Registration Date
Aug 07, 2020
Expiry Date
Jan 15, 2025
Product Type
Immunological Test System
Immunoglobulins A, G, M, D, and E immunological test system.
Invitro Diagnostics
Proline TruLab L Level 2
PROLINE TruLab L Level 1
PROLINE TruCal U
PROLINE TruLab N
Yumizen C Urine Level 1 Control
PROLINE Uric Acid FS TOOS
DSI Urea FS
TruLab Urine Level 1
TruLab Urine Level 2
TRULAB Bicarbonate
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

