iSIA Fluorescent Immuno Analyzer and Accessories - Indonesia BPOM Medical Device Registration
iSIA Fluorescent Immuno Analyzer and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304420020. The device is manufactured by CHONGQING ISIA BIO-TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HEALTHY FAMILY FOCUS.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. HEALTHY FAMILY FOCUSAR Address
Komplek Delta Building Blok B 1-2, Jalan Suryopranoto No. 1-9, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Gambir, Kel. Petojo Selatan
Registration Date
Mar 01, 2024
Expiry Date
May 05, 2028
Product Type
Immunology Laboratory Equipment and Reagents
Immunofluorometer equipment
Invitro Diagnostics
iSIA Total Thyroxine (TT4) Rapid Test Kit (QDs Immunofluorescence Method)
iSIA FT4 Rapid Test Kit (QDs Immunofluorescence Method)
iSIA Total Triiodothyronine (TT3) Rapid Test Kit (QDs Immunofluorescence Method)
fT3 Rapid Test Kit (QDs Immunofluorescent Method)
iSIA TSH (Thyroid-stimulating hormone) Rapid Test Kit (QDs Immunofluorescence Method)
AyoTes QD Based 25 Hydroxy vitamin D (25-OH VD) Test Kit
AyoTes QD Based Helicobacter pylori (HP typing: Cag A+ VacA+ Ure) Test Kit
AyoTes QD Based Troponin I (cTnI) Test Kit
AyoTes QD Based Procalcitonin (PCT) Test Kit
AyoTes QD Based C-reactive Protein (CRP+hs-CRP) Test Kit
AYOTES CLIA based Soluble Growth Stimulation Expressed Gene 2 Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA based Pepsinogen I (PGI) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA based ฮฑ - Fetoprotein Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA based Cytokeratin 19 Fragments Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Aldosteron Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Cortisol Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based 25-hydroxy-vitamin D (25-OH VD) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Testosterone Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Myoglobin (MYO) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA Based Creatine Kinase MB (CK-MB) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.