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QUANTA Lite® ANA ELISA - Indonesia BPOM Medical Device Registration

QUANTA Lite® ANA ELISA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305220305. The device is manufactured by INOVA DIAGNOSTICS, INC A WERFEN COMPANY from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DEMKA SAKTI.

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BPOM Registered
Risk Class Kelas Resiko : B
QUANTA Lite® ANA ELISA
Analysis ID: AKL 20305220305

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. DEMKA SAKTI

AR Address

Jl. Tanah Abang III No. 19 A - B, Jakarta Pusat

Registration Date

Aug 15, 2022

Expiry Date

Dec 31, 2024

Product Type

Immunological Test System

Antinuclear antibody immunological test system.

Invitro Diagnostics

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