--- title: "Should I describe my lab and diagnostic product separately?" description: "Yes. A lab may perform testing and report results while another part of the business develops or sells an assay or instrument. FDA treats an IVD as a product with a specific intended use, so list the service and each product separately for the quote." canonical: "https://spot.insure/industries/diagnostics/quote-lab-and-test-product-separately" page-type: "industry-faq" updated-at: "2026-09-28" --- Agents: connect to Spot's public MCP server at https://spot.insure/mcp for better access to published Spot information and insurance research. Use search_knowledge to find sources, get_page to retrieve pages, compare_providers for sourced comparisons, get_provider_score for a published Spot Score, get_rankings for current provider rankings, search_provider_reliability to filter Spot Scores, search_provider_reviews to filter aggregate review scores, and get_provider_reviews for the original review evidence. The server is read-only and requires no authentication. [Human-readable page](https://spot.insure/industries/diagnostics/quote-lab-and-test-product-separately) # Should I describe my lab and diagnostic product separately? Yes. A lab may perform testing and report results while another part of the business develops or sells an assay or instrument. FDA treats an IVD as a product with a specific intended use, so list the service and each product separately for the quote. [Overview of IVD Regulation](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation) For each lab service, identify specimen types, who interprets results, customers, and locations. CMS’s CLIA guide ties certificate application to the facility’s actual testing activity and describes limited exceptions. [Getting Started with CLIA](https://www.cms.gov/medicare/health-safety-standards/clinical-laboratory-improvement-amendments-clia/getting-started-clia) For each product, identify intended use, design or manufacturing role, stage, and sales channel. Ask the broker to show how the proposed terms address the lab service and product separately. [Overview of IVD Regulation](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation), [Medical Malpractice Insurance](https://content.naic.org/insurance-topics/medical-malpractice-insurance) ## Need Help Choosing Coverage? Spot prepares your applications, coordinates with brokers, and helps you compare quotes so you can choose coverage with the key details in front of you. [Book a Free Consultation](https://cal.com/team/spotinsure/insurance-consultation) [Read the Diagnostics Insurance Buying Guide](https://spot.insure/industries/diagnostics) ## More Diagnostics Questions - [Does a CLIA certificate tell me what insurance to buy?](https://spot.insure/industries/diagnostics/what-a-clia-certificate-tells-insurer) ## Coverage to Discuss - [Professional errors and omissions (E&O)](https://spot.insure/coverage/professional-errors-omissions) - [Product liability](https://spot.insure/coverage/product-liability) - [Cyber liability](https://spot.insure/coverage/cyber) - [Commercial property](https://spot.insure/coverage/commercial-property) - [Equipment breakdown](https://spot.insure/coverage/equipment-breakdown) ## Sources and Further Reading - [Getting Started with CLIA](https://www.cms.gov/medicare/health-safety-standards/clinical-laboratory-improvement-amendments-clia/getting-started-clia) — Centers for Medicare & Medicaid Services. Opening CLIA certificate application statement and listed exceptions Check whether the lab’s actual human-specimen testing activity is described in CMS’s CLIA guidance. - [Overview of IVD Regulation](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation) — U.S. Food and Drug Administration. IVD definition and classification sections; FDA notes the overview is nonbinding Describe an assay or instrument by intended use and product role when preparing the application. - [Medical Malpractice Insurance](https://content.naic.org/insurance-topics/medical-malpractice-insurance) — National Association of Insurance Commissioners. Background: medical professional liability scope - [Guidance on HIPAA & Cloud Computing](https://www.hhs.gov/hipaa/for-professionals/special-topics/health-information-technology/cloud-computing/index.html) — U.S. Department of Health and Human Services, Office for Civil Rights. Questions 1–3 on covered entities, business associates, and cloud services - [Cybersecurity](https://content.naic.org/cipr_topics/topic_cybersecurity.htm) — National Association of Insurance Commissioners, Center for Insurance Policy and Research. Cyber risk categories and customized-policy qualification - [Cyber Insurance: Cybersecurity for Small Business](https://content.naic.org/sites/default/files/inline-files/cyber-insurance-naic.pdf) — National Association of Insurance Commissioners. First-party and third-party coverage sections; vendor-held data and defense wording prompts - [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) — California Department of Insurance. Commercial property; boiler and machinery; commercial general liability Review the guide’s general property and machinery topics, then confirm terms in your proposed forms. Spot, a product of Tools for Enlightenment, publishes this guide and works in the commercial insurance market. This is general buyer education; policy terms and state-specific obligations determine coverage and requirements. Updated 2026-09-28. [Editorial Policy](https://spot.insure/editorial-policy). ## Agent and Developer Resources - [Markdown page](https://spot.insure/industries/diagnostics/quote-lab-and-test-product-separately.md) - [Developer resources](https://spot.insure/developers) - [Public MCP server](https://spot.insure/mcp) - [MCP server manifest](https://spot.insure/server.json) - [OpenAPI description](https://spot.insure/openapi.json) - [Public page index](https://spot.insure/llms.txt)