CLIA, FDA & ISO Equipment Standards
Understand regulatory requirements and ensure your lab equipment meets CLIA, FDA, CE, and ISO standards.
At Lab Equipment Direct, we know how important regulatory compliance is for clinical labs, biotech startups, universities, and diagnostics teams. We help you find equipment that’s not only high-quality but fully aligned with standards like CLIA, FDA, ISO, and CE.
🧬 What Compliance Means for You
Required for labs performing human diagnostic testing. We highlight CLIA-appropriate tools across categories.
For medical and diagnostic devices sold in the U.S., we flag FDA-listed, cleared, or approved items where applicable.
Indicates compliance with European safety and health regulations. Important for EU-bound labs and manufacturers.
We work with suppliers who manufacture under ISO 13485 or ISO 9001 to ensure consistent quality and traceability.
How We Support Compliance
✅ Clear product listings with spec sheets and certifications
✅ Downloadable manuals and documentation (when available)
✅ Direct supplier sourcing – no grey market equipment
✅ Dedicated support team to assist with regulatory questions
✅ We pre-vet FDA/CLIA relevance before listing products
Equipment with Certified Options
Autoclaves & Sterilization
💬 Need Help With Compliance?
Our support team is happy to guide you, whether you're setting up a CLIA lab, sourcing FDA-compliant tools, or just needing documentation to satisfy procurement.
📩 Contact us here or email support@labequipmentdirect.com.
Lab Equipment Direct is committed to making lab sourcing simple, certified, and stress-free.
📚 Frequently Asked Questions – Compliance & Regulatory
Do your products come with Certificates of Analysis or Calibration?
Yes. Most high-ticket equipment includes a COA or NIST-traceable calibration. If not listed, just request it—we’re happy to provide it before or after purchase.
How do I know if equipment is FDA or ISO compliant?
Each product page lists compliance information. You can also contact us to confirm FDA registration, ISO certification, or CE marking for specific items.
Can I get documentation before purchasing?
Absolutely. We’ll email sample certificates, validation files, or spec sheets upon request—just send the product SKU to support@labequipmentdirect.com.
Do you offer validation packages for GMP or GLP labs?
Yes. We supply IQ/OQ/PQ documents for qualifying equipment. If you're outfitting a regulated lab, let us know—we’ll help you stay compliant and audit-ready.
📥 Free Download: Lab Compliance Checklist
Stay audit-ready with our easy-to-follow checklist covering documentation, calibration, and regulatory prep for labs of any size.
Download Now (PDF)