Glossary Term
The international quality-management standard for medical device manufacturing. Certification does not certify individual products, but suppliers with ISO 13485-registered production generally support tender documentation more reliably.
Regulatory Definitions
Company
with our ISO 13485-certified in-vitro manufacturing.
Manufacturer
Company
All EntroGen products are manufactured in accordance with ISO 13485 standards.
Manufacturer
Company
vitro diagnostics (IVDs). We develop, manufacture and support an extensive portfolio of clinical diagnostic tests from our ISO 13485:2016-accredited facility in the United Kingdom.
Manufacturer
Company
All our products are manufactured in clean room of Class 10000, Equivalent to ISO 7 facilities, a prerequisite for GMP compliant.The PCR based Molecular Diagnostic
Manufacturer
Tests
The determination of the amount of 8-iso-prostaglandin F2 alpha in a biological specimen.
For professionals
Tests
The determination of the ratio of the 8-iso-prostaglandin F2 alpha to creatinine in a biological specimen.
For professionals
Article
Research record from Clin Lab, 2026-10-01. PMID 42847943.