The kits are designed and extensively tested in Germany and are manufactured in the US with components from Germany and the US.
All assays are strictly for Research Use Only. Not for use in any diagnostic procedure - these assays are not FDA approved. Kits are for internal testing by qualified laboratories. CE certification process pending.
(a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.
SARS-CoV-2 Related Products
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