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RaFIA Progesterone FIA Test - Indonesia BPOM Medical Device Registration

RaFIA Progesterone FIA Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323298. The device is manufactured by CTK BIOTECH, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. RAJAERBA INDOCHEM.

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BPOM Registered
Risk Class Kelas Resiko : B
RaFIA Progesterone FIA Test
Analysis ID: AKL 20101323298

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

CTK BIOTECH, INC.

Country of Origin

United States

Authorized Representative

PT. RAJAERBA INDOCHEM

AR Address

Jl. Hj. Tutty Alawiyah No. 8, Desa/Kelurahan Duren Tiga, Kec. Pancoran, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12760

Registration Date

Jun 16, 2023

Expiry Date

Aug 25, 2026

Product Type

Clinical Chemistry Test System

Progesterone test system (card)

Invitro Diagnostics

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