We are working on a medical device with QBD code; a specimen collection device /transport medium (ITM), Can any one shed light on the following ?
- Should the medium/device be tested for all the suitable sample types for ex; oropharyngeal/ anterior nasal swabs ?
- What kind of Validations are required to claim the device to be used as a part of the self-administered kit.
- For multiplex devices ex; influenzas/Covid , should such devices be tested for both these targets or would one of them be sufficient
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Deepthi Datla
Research compliance anlayst
Chicago IL
United States
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