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BGI Amino Acid and Carnitine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry) - Indonesia BPOM Medical Device Registration

BGI Amino Acid and Carnitine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101422253. The device is manufactured by BGI BIOTECHNOLOGY (WUHAN) CO. LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NALEYA GENOMIK INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
BGI Amino Acid and Carnitine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)
Analysis ID: AKL 20101422253

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. NALEYA GENOMIK INDONESIA

AR Address

Wisma MRA Lantai 18, Jalan TB. Simatupang Nomor 19

Registration Date

Nov 01, 2024

Expiry Date

Jul 26, 2029

Product Type

Clinical Chemistry Test System

Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry (kit & cair)

Invitro Diagnostics

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