TISENC D-Dimer (CLIA) - Indonesia BPOM Medical Device Registration
TISENC D-Dimer (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207220134. The device is manufactured by SHENZHEN TISENC MEDICAL DEVICES CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MITRA BAHAGIA CITRA MEDIKA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZHEN TISENC MEDICAL DEVICES CO., LTD.Country of Origin
China
Authorized Representative
PT. MITRA BAHAGIA CITRA MEDIKAAR Address
Jl. Raya Kalirungkut 27 Blok C-63
Registration Date
Sep 01, 2022
Expiry Date
Apr 21, 2027
Product Type
Haematology Package and Kit
Fibrinogen/fibrin degradation products assay.
Invitro Diagnostics
TISENC Dengue Virus IgG Antibody (CLIA)
TISENC Dengue Virus IgM Antibody (CLIA)
TISENC Dengue Virus NS1 Antigen (CLIA)
TISENC Ferritin (CLIA)
TISENC Procalcitonin (CLIA)
TISENC Creatine Kinase-MB (CLIA)
TISENC High Sensitive Cardiac Troponin I (CLIA)
TISENC TSH Thyroid-Stimulating Hormone (CLIA)
TISENC FT4 Free Thyroxine (CLIA)
TISENC FT3 Free Triiodothyronine (CLIA)
SENTINEL Cholesterol HDL Liquid NG
SENTINEL CH. SPA
SENTINEL Urea Liquid
SENTINEL CH. SPA
D-MACH Data Collection Mixer
CENTRON CORPORATION
TISENC Dengue Virus IgG Antibody (CLIA)
SHENZHEN TISENC MEDICAL DEVICES CO., LTD.
TISENC Dengue Virus IgM Antibody (CLIA)
SHENZHEN TISENC MEDICAL DEVICES CO., LTD.
TISENC Dengue Virus NS1 Antigen (CLIA)
SHENZHEN TISENC MEDICAL DEVICES CO., LTD.
SENTINEL ALT UV Liquid
SENTINEL CH. SPA
SENTINEL AST UV Liquid
SENTINEL CH. SPA
PROMOTOR HPV 18 High-Risk Types with 16/18 Genotyping Test Kit
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INSIGHT Expert U500 Urine Analyzer and Accessories
ACON BIOTECH (HANGZHOU) CO., LTD.