For distributors and health programs
Country Station: rapid test supply by country and region
The Country Station is the starting point for supply in your country. Find the rapid tests most relevant to your region, see which documents we provide and learn what a distributor needs to arrange locally.
- Supply outside the United States
- Distributor qualification
- Documents on request
What the Country Station is for
The rules for importing and selling in vitro diagnostic tests are set country by country. So are the diseases that matter most, the languages required on labels and the tests that fit national testing guidelines. The Country Station brings those questions into one place, so that a distributor or procurement team can see quickly what First Diagnostic™ Corporation can supply and what has to be arranged locally.
It covers our rapid tests and the lateral flow tests behind them. Country-specific status is confirmed case by case: tell us the country and the products, and we reply with what is available.
Regions
The tests listed for each region match common public health priorities there. Any product can be quoted for any region we supply.
Malaria P.f. antigen, HBsAg, HCV, the HIV / HBsAg / HCV combo and syphilis antibody tests.
Dengue IgG/IgM, HBsAg and HCV for hepatitis programs, influenza A and B, and STI tests.
Dengue IgG/IgM, syphilis, chlamydia and gonorrhea tests, and rubella IgG/IgM for prenatal care.
HBsAg and HCV, influenza A and B, cardiac markers and ToRCH serology for hospital and laboratory use.
Five products carry the CE mark on their insert. Ask us for the current regulatory documents for the product and country you need.
How supply to a new country starts
- Tell us the country and the products. Email sales@firstdiagnostic.com or use the contact page. Include expected volumes and whether you are a distributor, a health program or an end user.
- Receive the documents. We send the product inserts and the regulatory documents available for those products.
- Check local requirements. The distributor confirms what the national regulator requires for registration and import, including label language and any local testing.
- Complete distributor qualification. New distributors fill in the online application covering licences, storage, quality system and complaint handling.
- Quotation and order. We quote for the agreed products and pack sizes, with lot dating confirmed at order.
Who does what
| Topic | First Diagnostic provides | The distributor arranges |
|---|---|---|
| Product information | Inserts, catalog data and product pages | Translation where the country requires it |
| Regulatory | The documents available for each product | Product registration, import permits and local authorizations |
| Storage | Storage conditions as stated on the label | Storage and transport within those conditions |
| After-sales | Follow-up of product concerns with the manufacturer | First-line customer support and reporting of complaints with lot numbers |
Frequently asked questions
Which countries do you supply?
We supply distributors and institutions outside the United States. Availability depends on the product and on local registration requirements, so we confirm it for each request.
Is a product registered in my country?
Registration is held locally and varies by product. Ask us for the status in your market; where a product is not registered, the distributor normally applies with the documents we provide.
Can I be the exclusive distributor for my country?
Exclusivity is considered case by case after qualification and is never implied by an application or a first order.
Do you supply the United States?
No. 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.
Related
- Become a distributor — The qualification application for new distributors.
- Product inserts — Instructions for use to download.
- Quality and regulatory information — CE marking, intended users and how to report a concern.
- Services — What we do for distributors and manufacturers.
Ask about your country
Send the country, the products and your role. We will tell you what we can supply and which documents come with it.
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.