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ZYBIO TG Assay (CLIA) - Indonesia BPOM Medical Device Registration

ZYBIO TG Assay (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305220357. 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 TG Assay (CLIA)
Analysis ID: AKL 20305220357

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

Aug 29, 2022

Expiry Date

Jan 03, 2027

Product Type

Immunological Test System

Thyroid autoantibody immunological test system.

Invitro Diagnostics

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