FDA Approves five brand of Rapid Antibody Test Kits
2020-3-31 · This test kit is PCR based. To date, FDA has approved 17 PCR based test kits for commercial use. As a safety precaution, the FDA shall require the product inserts or label of the Rapid Test Kits to state the following: “This product is strictly for medical professional use only and not intended for personal use.
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