METER TRAX™ Control Mid - Indonesia BPOM Medical Device Registration

METER TRAX™ Control Mid is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208124727. The device is manufactured by BIORAD LABORATORIES INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DIASTIKA BIOTEKINDO.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

BPOM Registered

Risk Class Kelas Resiko : B

METER TRAX™ Control Mid

Analysis ID: AKL 20208124727

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIORAD LABORATORIES INC.

Country of Origin

United States

Authorized Representative

PT. DIASTIKA BIOTEKINDO

AR Address

Rukan Sentra Pemuda Kav.30 - 31 Jalan Pemuda No.61 RT.009 RW.003 Kel. Rawamangun Kec.Pulogadung

Registration Date

Feb 10, 2025

Expiry Date

May 31, 2028

Product Type

Hematological Reagents

Hematology quality control mixture.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from BIORAD LABORATORIES INC.

Products from the same manufacturer (10 products)

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : B

METER TRAX™ Control Mid - Indonesia BPOM Medical Device Registration

Risk Classification

Product Class

Manufacturer

Country of Origin

Authorized Representative

AR Address

Registration Date

Expiry Date

Product Type

DJ Fang

Liquichek™ Homocysteine Control Level 1

BIO-RAD Liquichek™ Homocysteine Control Level 3

METER TRAX Control Low

BIO-RAD METER TRAX Control High

D10 Hemoglobin A1c Program

VIROCLEAR

Lyphochek Tumor Marker Plus Control

VIROCLEAR ToRCH

BIORAD Lyphochek Coagulation Control Level 1

Lyphochek Coagulation Control Level 2

Liquichek™ Homocysteine Control Level 1

BIO-RAD Liquichek™ Homocysteine Control Level 3

METER TRAX Control Low

BIO-RAD METER TRAX Control High

ORTHO 0.8% SURGISCREEN

MGI Universal Sequencing Reaction Kit

MGI Universal Sequencing Reaction Kit

ORTHO SURGISCREEN

MP Diagnostics HIV BLOT 2.2 Western Blot Assay

ORTHO Anti-IgG/Anti-C3b, -C3d/Control Ortho BioVue System (DAT/IDAT Cassette)