Resource library

Diagnostics & IVD Resources

Diagnostics & IVD resources for component and reagent genealogy, kit revisions, QC evidence, expiry review and manufacturing software evaluation.

Guides: 2 guides
Glossary: 4 glossary entries
Checklist: 9 buyer questions

Manufacturing Record Dossier

Follow a lot-specific evidence index and retrieval exercise. Keep missing records, unresolved revisions and separate decisions visible; the index is not product-release authority.

GuideIVD Manufacturing Record DossierA worked evidence index: expected, retrieved and usable records, quantity explanations and two-way retrieval.Read the guide

Reference & Scope

Use this FDA overview for US IVD orientation, not as a current manufacturing-clause checklist. Your team distinguishes regulated IVD, research-use products and other markets; software does not determine regulatory status or patient results.

ReferenceFDA — Overview of IVD RegulationOfficial introductory overview of IVD scope and regulatory pathways; product and market applicability need separate review.Read the reference

Definitions and Adjacent Record Practices

Use the IVD definition for product scope and these existing medical-device guides for adjacent record questions. They are not IVD-specific approvals or a complete regulatory checklist.

Reagent Genealogy & Stability Evidence

Keep manufacturing identity, proposed stability claims and completed evidence distinct. These definitions do not supply a product-specific protocol or release authority.

Software Pages

Compare the production workflow and laboratory information with your own records, responsibilities and system boundaries.

Evaluate the software

Work through these questions with your production and quality teams, then use them to plan an evaluation with your own records.

IVD, Research Use and Market ScopeWhich products are regulated IVDs, research-use products or general laboratory reagents, and who documents their intended use and market classification?

Component, Reagent and Kit IdentityCan we follow one starting component through a formulated reagent lot, kit assembly and actual shipment without merging their separate identifiers?

Formulation and Assembly RevisionsCan our evaluation identify the approved formulation and kit assembly revisions actually assigned to a lot, including any substitutions and their review?

Material Status and Permission to UseWhich evidence must our team accept before a component is used, and how will pending, rejected and expired stock be distinguished?

Component and Kit Expiry EvidenceWho establishes component and kit dating, what evidence supports it, and how will we test the configured checks against our approved procedures?

Kit Issue and ReconciliationCan we reconcile issued, used, returned and rejected components against the assembled kit lot?

Pending and reviewed lot resultsWhich system owns lot QC and stability evidence, and how will missing results remain separate from completed and reviewed results?

Accountable Review and LabelingWho reviews exceptions, labels and any applicable identification obligations before documenting disposition, without assuming a universal kit exemption?

Manufacturing and Laboratory BoundariesWhich manufacturing records must link to our laboratory and inventory systems, and who owns reconciliation and intended-use testing rather than clinical patient-result services?

The existing production guide remains email-gated. Review its product, market and system scope with your responsible team; printing is available in the reader. Open the existing guide offer.

Explore the workflow

The illustrated five-step workflow follows component receipt and hold, reagent formulation, filling and kit assembly, lot testing, and label checks and human review before shipment.

Explore the diagnostics & ivd workflow