QUANTA Lite® ANA ELISA - Indonesia BPOM Medical Device Registration
QUANTA Lite® ANA ELISA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305520072. 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. SENTRUM DIAGNOSTIK INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
INOVA DIAGNOSTICS, INC A WERFEN COMPANYCountry of Origin
United States
Authorized Representative
PT. SENTRUM DIAGNOSTIK INDONESIAAR Address
Jl. Raya Rawa Bambu No. 15 B Rt. 013, Rw. 005
Registration Date
Feb 07, 2025
Expiry Date
Jun 12, 2029
Product Type
Immunological Test System
Antinuclear antibody immunological test system.
Invitro Diagnostics
