LIFOTRONIC D-Dimer STAT (eCLIA) - Indonesia BPOM Medical Device Registration
LIFOTRONIC D-Dimer STAT (eCLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207320399. The device is manufactured by SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. LIFOTRONIC TECHNOLOGY INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTDCountry of Origin
China
Authorized Representative
PT. LIFOTRONIC TECHNOLOGY INDONESIAAR Address
Ruko South Goldfinch Blok SGA No. 17, Jl. Spring Boulevard, Kode Pos 15322, Kel. Cihuni, Kec. Pagedangan, Kab. Tangerang, Provinsi Banten
Registration Date
Sep 07, 2023
Expiry Date
Mar 13, 2028
Product Type
Haematology Package and Kit
Fibrinogen/fibrin degradation products assay.
Invitro Diagnostics
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LIFOTRONIC Vitamin B12 (eCLIA)
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LIFOTRONIC High-Sensitivity C-reactive Protein (Electrochemiluminescence Immunoassay)
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LIFOTRONIC Luteinizing Hormone (Electrochemiluminescence Immunoassay)
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LIFOTRONIC Anti-Mullerian Hormone (eCLIA)
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LIFOTRONIC Interleukin-6 (Electrochemiluminescence Immunoassay)
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LIFOTRONIC Free Thyroxine Kit (Electrochemiluminescence Immunoassay)
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LIFOTRONIC Creatine Kinase MB (Electrochemiluminescence Immunoassay)
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LIFOTRONIC Thyroid Peroxidase Antibody (Electrochemiluminescence Immunoassay)
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LIFOTRONIC Ferritin (Electrochemiluminescence lmmunoassay)
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.

