What is an in vitro diagnostic product (IVD)? Def
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Posted On: 09/08/2022 3:10:16 PM
What is an in vitro diagnostic product (IVD)?
Definition: In vitro diagnostic products are those reagents, instruments, and systems intended for use in 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. [21 CFR 809.3]
Vac-check does not use a sample taken from the body, it takes it from the vaccine vial and the remaining vaccine spiked with QDs then goes into the body.
Definition: In vitro diagnostic products are those reagents, instruments, and systems intended for use in 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. [21 CFR 809.3]
Vac-check does not use a sample taken from the body, it takes it from the vaccine vial and the remaining vaccine spiked with QDs then goes into the body.
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