Assay Cup - Indonesia BPOM Medical Device Registration
Assay Cup is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10203320171. The device is manufactured by SHENZHEN LIFOTRONIC TECHNOLOGY CO.,LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is LIFOTRONIC TECHNOLOGY INDONESIA.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
SHENZHEN LIFOTRONIC TECHNOLOGY CO.,LTD.Country of Origin
China
Authorized Representative
LIFOTRONIC TECHNOLOGY INDONESIAAR Address
LIFOTRONIC TECHNOLOGY INDONESIA
Registration Date
Mar 15, 2023
Expiry Date
Oct 01, 2027
Product Type
Pathology Equipment and Accessories
Specimen transport and storage container.
Invitro Diagnostics
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LIFOTRONIC Microalbumin (mAlb) Assay Kits (Lateral Flow Immunoassay)
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LIFOTRONIC Triiodothyronine (T3) Assay Kits (Lateral Flow Immunoassay)
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LIFOTRONIC Thyroid Stimulating Hormone (TSH) Assay Kits (Lateral Flow Immunoassay)
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LIFOTRONIC Lateral Flow Immunoassay Analyzer FA-160
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LIFOTRONIC High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA
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