Quality and regulatory
Quality and regulatory information for our rapid tests
What we can tell you about how our rapid tests are sourced, documented and regulated, stated as plainly as we can.
- Professional in vitro diagnostic use
- Reviewed October 2026
How our rapid tests are sourced
First Diagnostic™ Corporation brands and distributes lateral flow rapid tests made by established IVD manufacturers. We do not manufacture tests. The instructions for use packed with each kit define the intended use, the procedure and the performance of that product.
Intended users
The products with pages on this site are for professional in vitro diagnostic use by trained healthcare and laboratory staff. For items supplied on request, the insert states the intended user. Results are an aid to diagnosis and must be interpreted with other clinical and laboratory findings.
CE marking shown on product inserts
This table reports what is printed on the insert we publish for each product.
| Product | CE mark on insert | Insert |
|---|---|---|
| ATFirst™ HBsAg | Yes | Published |
| inSTIcheck™ Chlamydia | Yes | Published |
| inSTIcheck™ Gonorrhea | Yes | Published |
| ATFirst™ Malaria P.f. | Yes | Published |
| ATFirst™ Rubella IgG/IgM | Yes | Published |
| ATFirst™ HIV / HBsAg / HCV combo | Not shown | Published |
| ATFirst™ HCV | Not shown | Published |
| inSTIcheck™ Syphilis | Not shown | Published |
| ATFirst™ Dengue IgG/IgM | Not shown | Published |
| ATFirst™ Flu A & B | Not shown | Laboratory procedure published |
| Other products | Documentation on request | On request |
Ask for the current declaration of conformity or certificate for the product and country you need.
United States
Products shown on this website are not cleared, approved or authorized by the U.S. Food and Drug Administration and are not offered for sale in the United States.
Registration in your country
Most countries require in vitro diagnostic tests to be registered or notified before sale, and the requirement differs by product type. Registration is usually held by the local distributor or importer. We provide the documents available for each product; the Country Station describes how the process starts.
Reporting a product concern
If a test does not perform as the insert describes, email sales@firstdiagnostic.com with the product name, catalog number, lot number, expiry date and a description of what happened. Keep the affected kits. We follow up each report with the manufacturer.
How we check what this website says
Each product page names its source: the published insert, or our catalog where no insert is published. Performance figures are published only where the insert reports them with the comparator method and sample counts, and the figures agree with its data table. Where we do not publish an insert, the page gives catalog facts and no performance claims. Pages show their last review date, and corrections can be sent to sales@firstdiagnostic.com.
Frequently asked questions
Can you send a certificate or declaration of conformity?
Ask for the product and country you need and we will send the documents available.
Who is the manufacturer of a given test?
Each test is made by an IVD manufacturer for First Diagnostic. Manufacturer details needed for registration are part of the documentation shared with qualified distributors.
Are the tests suitable for self-testing?
No. The products with pages on this site are for professional use only.
Related
- Product inserts — Instructions for use to download.
- What is a medical device? — How devices and in vitro diagnostics are defined and classified.
- Lateral flow tests explained — How the tests work and what results mean.
- Rapid tests catalog — All product ranges.
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.