ORTHO Anti-IgG/Anti-C3b, -C3d/Control Ortho BioVue System (DAT/IDAT Cassette) - Indonesia BPOM Medical Device Registration
ORTHO Anti-IgG/Anti-C3b, -C3d/Control Ortho BioVue System (DAT/IDAT Cassette) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305420549. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DIASTIKA BIOTEKINDO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ORTHO-CLINICAL DIAGNOSTICSCountry of Origin
United Kingdom
Authorized Representative
PT. DIASTIKA BIOTEKINDOAR Address
Rukan Sentra Pemuda Kav.30 - 31 Jalan Pemuda No.61 RT.009 RW.003 Kel. Rawamangun Kec.Pulogadung
Registration Date
Nov 04, 2024
Expiry Date
Feb 14, 2027
Product Type
Immunological Test System
Immunoglobulins A, G, M, D, and E immunological test system.
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