YHLO iFlash CA 19-9 - Indonesia BPOM Medical Device Registration
YHLO iFlash CA 19-9 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306027433. The device is manufactured by SHENZHEN YHLO BIOTECH CO,,LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZHEN YHLO BIOTECH CO,,LTDCountry of Origin
China
Authorized Representative
PT. FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
May 20, 2022
Expiry Date
Feb 04, 2026
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
Invitro Diagnostics
YHLO UNICELL-cTnI
YHLO UNICELL CK-MB
YHLO UNICELL-NT-proBNP
YHLO iFlash Toxo IgG (CLIA)
YHLO iFlash CMV IgG (CLIA)
YHLO iFlash Anti TP (Antibody To Treponema Pallidum) CLIA
YHLO UNICELL D-DIMER
YHLO iFlash Free PSA (CLIA)
YHLO iFlash CEA
YHLO iFlash CA 15-3 (Cancer Antigen 15-3)
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