QUANTA LITE® ß2GPI IgG ELISA - Indonesia BPOM Medical Device Registration
QUANTA LITE® ß2GPI IgG ELISA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305220323. The device is manufactured by INOVA DIAGNOSTICS, INC A WERFEN COMPANY from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DEMKA SAKTI.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
INOVA DIAGNOSTICS, INC A WERFEN COMPANYCountry of Origin
United States
Authorized Representative
PT. DEMKA SAKTIAR Address
Jl. Tanah Abang III No. 19 A - B, Jakarta Pusat
Registration Date
Aug 11, 2022
Expiry Date
Dec 31, 2024
Product Type
Immunological Test System
Beta -2-glycoprotein I immunological test system.
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