Services & channels

Medical device sales representation for diagnostic manufacturers

First Diagnostic™ Corporation offers medical device sales representation to manufacturers of diagnostic products who want to reach distributors and institutional buyers. This page sets out what the service covers and what it does not.

How medical device sales representation works at First Diagnostic

Under medical device sales representation, the manufacturer keeps its own brand, sets its prices and invoices its customers. First Diagnostic introduces the product line to distributors and supports the sales process.

The company was founded in 2004. It brands and distributes lateral flow tests made by established IVD manufacturers, listed in the rapid tests catalog under categories such as hepatitis and HIV rapid tests, so representation draws on the same distributor contacts and paperwork routines. The general model is explained in what is a manufacturer’s representative.

What the service covers

  • Market introductions to distributors. We present the product line to distributors of diagnostic products in the markets agreed with the manufacturer, and pass on their questions and feedback.
  • Catalog and labeling coordination. We help align catalog numbers, pack descriptions, product sheets and the language versions of labeling that distributors ask for. Label content and claims stay under the manufacturer’s control.
  • Distributor qualification. We collect company details, import and storage capability, market coverage and references before a distributor is proposed to the manufacturer. The process mirrors our own distributor application.
  • Order processing support. We coordinate quotations, order confirmations, shipping documents and follow-up between distributor and manufacturer.

What remains the manufacturer's responsibility

Regulatory clearance for each market remains the manufacturer’s responsibility. That includes the technical documentation, performance data, labeling claims, quality system and post-market obligations for the product.

First Diagnostic does not promise access to any market, including the United States, and does not guarantee sales volumes. A product can be introduced only in markets where the manufacturer confirms that it may lawfully be sold. Our quality and regulatory information explains how we handle documentation for our own range.

What we ask from a manufacturer

To assess a product line we ask for:

  • the current instructions for use and intended-use statement;
  • the regulatory status in each target market, with supporting certificates;
  • the quality management system certificate;
  • shelf life, storage conditions, pack formats and minimum order quantities;
  • existing distributor agreements, so territories do not overlap.

Product types we can discuss include rapid tests, readers and laboratory instruments such as biochemistry lab analyzers. The full list of services is on the services page. To start, contact us at sales@firstdiagnostic.com with the documents above.

Frequently asked questions

No. We introduce products to distributors and support the sales process. Regulatory clearance for each market remains the manufacturer’s responsibility, and we do not promise access to any market, including the United States.

Under representation the manufacturer keeps its own brand, pricing and invoicing. ATFirst™ and inSTIcheck™ products are branded and distributed by First Diagnostic.

In vitro diagnostic and point-of-care products for professional use, with documentation the manufacturer can share with distributors.

Regulatory status: Products shown on this website are for professional in vitro diagnostic use. They are not cleared, approved or authorized by the U.S. Food and Drug Administration and are not offered for sale in the United States. Product availability and regulatory status vary by country; contact us for the status in your market.