PRESTIGE Diagnostic ALT(GPT) - Indonesia BPOM Medical Device Registration
PRESTIGE Diagnostic ALT(GPT) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101813363. The device is manufactured by PRESTIGE DIAGNOSTICS U.K LTD. from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PELITA MANDIRI SENTOSA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
PRESTIGE DIAGNOSTICS U.K LTD.Country of Origin
United Kingdom
Authorized Representative
PT. PELITA MANDIRI SENTOSAAR Address
Jl. Boulevard Barat Raya, Komplek Kokan Inkopal KTC Blok F No. 66 Kelapa Gading, Jakarta Utara
Registration Date
Jul 05, 2022
Expiry Date
Jul 01, 2025
Product Type
Clinical Chemistry Test System
Alanine amino transferase (ALT/SGPT) test system (kit & cair)
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