ZYBIO 25-hydroxyvitamin D Assay (Immunofluorescence) - Indonesia BPOM Medical Device Registration
ZYBIO 25-hydroxyvitamin D Assay (Immunofluorescence) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221304. The device is manufactured by ZYBIO INC from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ZYBIO MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ZYBIO INCCountry of Origin
China
Authorized Representative
PT. ZYBIO MEDICAL INDONESIAAR Address
MGK office tower B, lantai 8, Unit 8B, Jl, Angkasa Kavling B-6, Kota Adm, Jakarta Pusat, Provinsi DKI Jakarta 10610
Registration Date
Sep 19, 2022
Expiry Date
Jan 03, 2027
Product Type
Clinical Chemistry Test System
Vitamin D test system (kit & cair)
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