BIOSSAYS™ ALT Alanine Aminotransferase Assay Kit (IFCC) - Indonesia BPOM Medical Device Registration
BIOSSAYS™ ALT Alanine Aminotransferase Assay Kit (IFCC) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101818090. 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. MULTI SYNERGY ANUGRAH SEJAHTERA.
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Risk Classification
Product Class
Kelas : 2
Country of Origin
China
Authorized Representative
PT. MULTI SYNERGY ANUGRAH SEJAHTERAAR Address
JL. Wonodri Sendang Raya No. 10, RT 4 / RW 5 Kel. Wonodri Kec. Semarang Selatan
Registration Date
Nov 29, 2023
Expiry Date
Dec 31, 2025
Product Type
Clinical Chemistry Test System
Alanine amino transferase (ALT/SGPT) test system (kit & cair)
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