YHLO iFlash-PCT (Procalcitonin) - Indonesia BPOM Medical Device Registration
YHLO iFlash-PCT (Procalcitonin) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303121543. The device is manufactured by SHENZHEN YHLO BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. 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., LTD.Country of Origin
China
Authorized Representative
PT. FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Jun 13, 2022
Expiry Date
Feb 04, 2026
Product Type
Serological Reagents
Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis
Invitro Diagnostics
HUMAN HumaSRate 24PT and Accessories
YHLO HBsAg Control
YHLO UNICELL-AMH
YHLO UNICELL-PCT
YHLO UNICELL-S Immunofluorescence Reader dan Accessories
YHLO iFlash-Mycoplasma pn. IgM
YHLO iFlash-Chlamydia pn. IgM
YHLO iFlash-Chlamydia pn. IgG
YHLO iFlash-EB NA IgA
YHLO iFlash-EB EA IgM
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