AyoTes HbA1c Calibrator - Indonesia BPOM Medical Device Registration
AyoTes HbA1c Calibrator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208320426. The device is manufactured by SHENZHEN LIFOTRONIC 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
SHENZHEN LIFOTRONIC 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
Registration Date
Feb 07, 2023
Expiry Date
Feb 03, 2026
Product Type
Hematological Reagents
Calibrator for hemoglobin or hematocrit measurement.
Invitro Diagnostics
LIFOTRONIC Luteinizing Hormone (Electrochemiluminescence Immunoassay)
LIFOTRONIC Anti-Mullerian Hormone (eCLIA)
LIFOTRONIC High-Sensitivity C-reactive Protein (Electrochemiluminescence Immunoassay)
LIFOTRONIC 25-OH Vitamin D Total (Electrochemiluminescence Immunoassay)
LIFOTRONIC Temperature Management System
LIFOTRONIC Auffer
LIFOTRONIC Buffer
LIFOTRONIC Procalcitonin (Electrochemiluminescence Immunoassay)
Assay Cup
Lifotronic Concentrated Washing Buffer
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