Resources: Documentation, Certificates and Validation Records
Quick Answer — This section is being built as a structured document library. Until it is complete, current documents are supplied on request, and this page exists so that buyers know exactly what to ask for, what each document contains, and what is not yet available.
What belongs in a document library
| Document | What it contains | Who needs it |
|---|---|---|
| IFU (instructions for use) | Intended use, specimen, procedure, performance, limitations | Every user; registration dossiers |
| CoA (certificate of analysis) | Batch-specific test results against specification | Quality review, release testing |
| Validation summary | Analytical and clinical performance, with methods | Distributors, tender evaluation |
| TDS (technical data sheet) | Specifications in a comparable format | Procurement, technical evaluation |
| QMS certificates | ISO 13485 / ISO 9001, with scope | Registration, supplier qualification |
| SDS | Handling and transport safety information | Logistics, customs, workplace safety |
What is available now
Data pending. This section reports measured values from internal validation studies. They are published once the supporting study is complete; the current report is available from technical support on request.
How to request
Requests are handled by technical support. To make the response useful, include:
- Product name and catalogue number.
- The reagent lot, if the request concerns a specific batch.
- The document type required (IFU, CoA, validation summary, certificate).
- The intended purpose — registration, tender, internal qualification — because the required format differs.
Data pending. This section reports measured values from internal validation studies. They are published once the supporting study is complete; the current report is available from technical support on request.
Version control matters more than the document
An IFU without a version number and effective date is not usable in a registration dossier, and it is dangerous in practice: procedures and performance claims change between revisions. When you receive a document, check:
- The version identifier and effective date.
- Whether it applies to the reagent lot you hold.
- Whether the performance figures match those published on the technical pages of this site.
If they do not match, treat the mismatch as information rather than as noise — it may indicate an older document in circulation.
Why this page lists gaps
Most vendor resource pages present a complete-looking set of icons. In practice, document availability varies by product, by market and by product generation, and discovering a gap during a tender submission is expensive for the buyer.
Data pending. This section reports measured values from internal validation studies. They are published once the supporting study is complete; the current report is available from technical support on request.
The Author’s Take
Position. A document library is the highest-return page on a diagnostic site, and the honest version — with visible gaps — outperforms the complete-looking version that cannot be defended.
Reasoning. Registration and tender processes are document-driven: a distributor’s timeline is set by how long it takes to assemble a dossier, and every missing certificate is a week. A vendor who publishes what exists, what does not, and how to request it removes the worst part of that process — the uncertainty. The temptation is to present a full set of icons because competitors do; but a buyer who clicks four empty icons concludes the vendor is disorganised, while a buyer who sees an accurate status table concludes the vendor knows its own documentation. The second impression is worth more, and it is the only one that survives contact with an actual request.
Disclosure. This page is a structural placeholder pending document publication. markers indicate where current status, request routes and available document types must be inserted.
Related pages
- Regulatory compliance · Support and downloads
- Analytical performance · Validation status on the research page
- Shipping, returns and warranty
Sources
- Reference to be added.
- Reference to be added.
Frequently asked questions
- Can I download an IFU directly from this site?
- Not yet. Electronic copies of current instructions for use are available on request from technical support while the document library is being published. Always confirm the version and effective date of any IFU you receive.
- What should a distributor request before registration?
- The current IFU with its version and effective date, the certificate of analysis for the specific batch, quality management certificates with their scope, and any available validation summary. Ask specifically which documents are available and which are not.
- Why do you publish a list of what is not available?
- Because a buyer planning a registration or a tender needs to know the boundary before they commit. A document list that implies completeness and then delivers gaps costs more time than one that is honest from the start.