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

ZYBIO SARS-CoV-2 Antibody Assay (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220866. 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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BPOM Registered
Risk Class Kelas Resiko : B
ZYBIO SARS-CoV-2 Antibody Assay (CLIA)
Analysis ID: AKL 20303220866

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ZYBIO INC.

Country of Origin

China

Authorized Representative

PT. 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

Dec 08, 2022

Expiry Date

Dec 05, 2023

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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