MAGLUMI Osteocalcin (CLIA) - Indonesia BPOM Medical Device Registration

MAGLUMI Osteocalcin (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101520239. The device is manufactured by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SNIBE DIAGNOSTIC INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : B

MAGLUMI Osteocalcin (CLIA)

Analysis ID: AKL 20101520239

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.

Country of Origin

China

Authorized Representative

PT. SNIBE DIAGNOSTIC INDONESIA

AR Address

TEMPO SCAN TOWER, LANTAI 21, JALAN H.R. RASUNA SAID KAV. 3-4

Registration Date

Feb 03, 2025

Expiry Date

Aug 13, 2029

Product Type

Clinical Chemistry Test System

Alkaline phosphatase or isoenzymes test system (kit & cair)

Invitro Diagnostics

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MAGLUMI Osteocalcin (CLIA) - Indonesia BPOM Medical Device Registration

Risk Classification

Product Class

Manufacturer

Country of Origin

Authorized Representative

AR Address

Registration Date

Expiry Date

Product Type

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MAGLUMI Anti-β2-Glycoprotein 1 IgG (CLIA)

MAGLUMI Anti-Cardiolipin IgA (CLIA)

MAGLUMI AMH (CLIA)