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Zybio SARS-CoV-2 Neutralizing Antibody Assay (CLIA) - Indonesia BPOM Medical Device Registration

Zybio SARS-CoV-2 Neutralizing Antibody Assay (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220855. The device is manufactured by ZYBIO INC. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ZYBIO MEDICAL INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
Zybio SARS-CoV-2 Neutralizing Antibody Assay (CLIA)
Analysis ID: AKL 20303220855

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ZYBIO INC.

Country of Origin

China

Authorized Representative

ZYBIO MEDICAL INDONESIA

AR Address

MGK office tower B, lantai 8, Unit 8B, Jl, Angkasa Kavling B-6, Kota Adm, Jakarta Pusat, Provinsi DKI Jakarta 10610

Registration Date

May 12, 2022

Expiry Date

Jan 12, 2023

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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