ADVANCED QUALITY™ One Step TP (Treponema Pallidum/Syphilis) Test Card (Serum/Plasma/Whole Blood) - Indonesia BPOM Medical Device Registration

ADVANCED QUALITY™ One Step TP (Treponema Pallidum/Syphilis) Test Card (Serum/Plasma/Whole Blood) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303901343. The device is manufactured by INTEC PRODUCTS INC.,P.R from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TRUE MITRASAMAYA.

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BPOM Registered

Risk Class Kelas Resiko : C

ADVANCED QUALITY™ One Step TP (Treponema Pallidum/Syphilis) Test Card (Serum/Plasma/Whole Blood)

Analysis ID: AKL 20303901343

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

INTEC PRODUCTS INC.,P.R

Country of Origin

China

Authorized Representative

PT. TRUE MITRASAMAYA

AR Address

RUKAN KENCANA NIAGA BLK D.1 NO.2.J,KEMBANGAN

Registration Date

Sep 17, 2024

Expiry Date

Apr 17, 2029

Product Type

Serological Reagents

Treponema pallidum treponemal test reagents.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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