Laboratory Test Request

COVID-19 Antigen Kits FDA Medical Device Performance Testing

Project Description

EU Manufacturer of Covid-19 test kits (antigen test kits for home use) needs FDA Medical Device Laboratory to perform performance studies for their covide 19 antigenkits.
- Are you FDA authorized lab and able to perform the performance studies for medical devices including Covid19 Antigen kits?
- How many samples should we send you to perform the performance studies?
- Can you give estimated total duration and cost breakdown for the entire process?
- Will you provide results directly to FDA or us to use in our submission?
- Is there anything else that we need to provide to initiate the process?

Project Information

Number:22-00499

Industry:Medical Devices (Electrical)

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Biotechnology,Clinical Diagnostic,Healthcare and Medical,Immunotherapy and Immunotherapeutics,In-Vitro Diagnostics,Laboratory Equipment,Medical Devices,Medical Disposables,Medical Equipment,

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