REALY TECH ™ Alpha-fetoprotein (AFP) Assay - Indonesia BPOM Medical Device Registration
REALY TECH ™ Alpha-fetoprotein (AFP) Assay is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320333. The device is manufactured by HANGZHOU REALY TECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. NUSANTARA BINA DIAGNOSTIKA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
HANGZHOU REALY TECH CO., LTD.Country of Origin
China
Authorized Representative
PT. NUSANTARA BINA DIAGNOSTIKAAR Address
Pertokoan Bali View No. 35 Jl. Rajawali Pisangan Ciputat, Tangerang Selatan
Registration Date
Nov 14, 2023
Expiry Date
Aug 30, 2026
Product Type
Tumor Antigen Immunologic Test System
AFP-L3% immunological test system.
Invitro Diagnostics
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REALY TECH ™ High Sensitivity C-Reactive Protein (hsCRP) Assay Reagent Kit (CMIA)
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REALY TECH™ Herpes Simplex Virus -1/2 IgG (HSV-1/2 IgG) Assay Reagent Kit (CMIA)
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REALY TECH™ D-Dimer (DD) Assay Reagent Kit (CMIA)
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REALY TECH ™ Total Immunoglobulin E (Total IgE) Assay Reagent Kit (CMIA)
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REALY TECH™ 25-Hydroxy Vitamin D (25-OH VD) Assay Reagent Kit(CMIA)
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REALY TECH ™ Anti-Mullerian Hormone (AMH) Assay Reagent Kit (CMIA)
HANGZHOU REALY TECH CO., LTD.
REALY TECH ™ Procalcitonin (PCT) Assay Reagent Kit (CMIA)
HANGZHOU REALY TECH CO., LTD.