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AmplideX Fragile X Dx & Carrier Screen Kit - Indonesia BPOM Medical Device Registration

AmplideX Fragile X Dx & Carrier Screen Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305320931. The device is manufactured by ASURAGEN, INC., from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. NUTRILAB PRIMARY.

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BPOM Registered
Risk Class Kelas Resiko : C
AmplideX Fragile X Dx & Carrier Screen Kit
Analysis ID: AKL 20305320931

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

ASURAGEN, INC.,

Country of Origin

United States

Authorized Representative

PT. NUTRILAB PRIMARY

AR Address

JLN. RAYA KEBAYORAN LAMA NO.18, RT 001, RW 013, KEL. GROGOL UTARA, KEC KEB LAMA JAKARTA SELATAN 12210.

Registration Date

Jun 24, 2023

Expiry Date

Feb 17, 2025

Product Type

Immunological Test System

Genetic health risk assessment system

Invitro Diagnostics

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