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HOTGEN FT4-CLIA Free Tyroxine Test (Chemiluminescence Immunoassay) - Indonesia BPOM Medical Device Registration

HOTGEN FT4-CLIA Free Tyroxine Test (Chemiluminescence Immunoassay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421019. The device is manufactured by BEIJING HOTGEN BIOTECH CO.ID from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ZEFINDO DARYA MEGATAMA.

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BPOM Registered
Risk Class Kelas Resiko : B
HOTGEN FT4-CLIA Free Tyroxine Test (Chemiluminescence Immunoassay)
Analysis ID: AKL 20101421019

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. ZEFINDO DARYA MEGATAMA

AR Address

Jl. Jemursari No 329-331 B, Kode Pos 60239, Desa/Kelurahan Sidosermo, Kec. Wonocolo, Kota Surabaya, Prov. Jawa Timur

Registration Date

May 31, 2024

Expiry Date

Nov 28, 2028

Product Type

Clinical Chemistry Test System

Free thyroxine test system (kit & cair)

Invitro Diagnostics

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