Quality & Accreditations

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Quality Assurance is essential to the success and future endeavours of Newmarket Biomedical. We hold certification for ISO 13485 and MDSAP from the British Standards Institute (BSI) and we are compliant with Directive 98/87/EC and Regulation (EU) 2017/746 for in vitro diagnostic medical devices.

Further improvements to the Quality Management System (QMS) are continually being undertaken throughout the company and are implemented enthusiastically by all staff members.

Our Quality Policy underlines our desire for high quality products and service, our dedication to the necessary regulatory requirements and our commitment to the growth and support of our staff.

Certifications

Quality Policy

Quality Management System ISO 13485:2016 and En ISO 13485:2016

IVDR 739694 R000

Quality Management System – ISO 13485:2016 – MDSAP

Instructions For Use

NewBio TPHA Instructions for Use (EN)

NewBio TPHA Instructions for Use (FR)

NewBio RPR Instructions for Use (EN)

NewBio TPHA Instructions for Use (DE)

NewBio Syphilis EIA TA Instructions for use (EN)

NewBio RPR Instructions for use (DE)

Safety Data Sheets

TPHA Kits Safety Data Sheet (EN)

PK7400 TP HA Controls Safety Data Sheet (FR)

TPHA Control Cells Safety Data Sheet (DE)

TPHA Kits Safety Data Sheet (DE)

PK7400 TP HA Controls Safety Data Sheet (NL)

TPHA Sample Diluent Safety Data Sheet (EN)

PK TPHA 2000 Safety Data Sheet (EN)

RPR Carbon Antigen Safety Data Sheet (EN)

TPHA Sample Diluent Safety Data Sheet (DE)

RPR Kits Safety Data Sheet (EN)

RPR Carbon Antigen Safety Data Sheet (DE)

TPHA Positive Control – Diluted Safety Data Sheet (EN)

RPR Kits Safety Data Sheet (DE)

RPR Positive Control – Human Safety Data Sheet (EN)

TPHA Positive Control – Diluted Safety Data Sheet (DE)

PK7400 TP HA Reagent Safety Data Sheet (EN)

RPR Positive Control – Human Safety Data Sheet (DE)

TPHA Negative Control – Concentrated Safety Data Sheet (EN)

PK7400 TP HA Reagent Safety Data Sheet (DE)

RPR Negative Control Safety Data Sheet (EN)

TPHA Negative Control – Concentrated Safety Data Sheet (DE)

PK7400 TP HA Reagent Safety Data Sheet (FR)

RPR Negative Control Safety Data Sheet (DE)

TPHA Negative Control – Diluted Safety Data Sheet (EN)

PK7400 TP HA Reagent Safety Data Sheet (NL)

TPHA Test Cells Safety Data Sheet (EN)

TPHA Negative Control – Diluted Safety Data Sheet (DE)

PK7400 TP HA Controls Safety Data Sheet (EN)

TPHA Test Cells Safety Data Sheet (DE)

TPHA Negative Control – Diluted Safety Data Sheet (DE)

PK7400 TP HA Controls Safety Data Sheet (DE)

TPHA Control Cells Safety Data Sheet (EN)

TPHA Positive Control – Human Concentrated Safety Data Sheet (DE)