For export only
We can supply for the export purposes a huge variety of different rapid diagnostic test kits, which are not approved for the sale in United States, because of different reasons. For example we have a list of tests for detection of sexual transmitted diseases, infectious diseases, tumor markers etc. All these test kits legal for research purposes or export mainly because government afraid of people test result reading mistakes that could initiate dramatically dangerous actions. Like for example, some person find out that his or her HIV test show a positive result. After that we can not prognoses what he or she will do. At the same time all the rapid test result are only preliminary and required laboratory confirmation. Regular person can make a mistake in the testing procedure and result obtained could be wrong.
According to United States law and FDA regulations, any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval.
But, in addition, the buyers/importers must meet the terms of the laws in the importing country.
The law in some countries possibly will necessitate written certification that an exporting company or rapid test devices are legal. In such occasion FDA could provides a Certificate for Foreign Government (CFG).
A health care appliance which would be consider to be counterfeited or misbranded, may be sell for export under regulations of Section 801 provided the product is proposed exclusively for export.
Although such a device would not meet the domestic requirements of the FDA regulations and other U.S law, it may be exported legally without additional FDA permission if this product:
- Manufactured according to the specifications of the foreign buyer;
- Products in accordance with the importing country laws;
- Packaging of the order includes label that it is for export only; and not sold or offered for sale in United States.
If you have in mind any rapid diagnostic device to order it from us, don't hesitate to send us request.
If it will be a real and legal product, we will do it for you.
To send your request, just click here and fill up this form, please.
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