LIFOTRONIC Thyroglobulin (Electrochemiluminescence Immunoassay) - Indonesia BPOM Medical Device Registration

LIFOTRONIC Thyroglobulin (Electrochemiluminescence Immunoassay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305320748. The device is manufactured by SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD, CHINA from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. LIFOTRONIC TECHNOLOGY INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : B

LIFOTRONIC Thyroglobulin (Electrochemiluminescence Immunoassay)

Analysis ID: AKL 20305320748

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD, CHINA

Country of Origin

China

Authorized Representative

PT. LIFOTRONIC TECHNOLOGY INDONESIA

AR Address

LIFOTRONIC TECHNOLOGY INDONESIA

Registration Date

Mar 06, 2023

Expiry Date

Oct 01, 2027

Product Type

Immunological Test System

Thyroid autoantibody immunological test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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