fda
2 records
FDA Recall: PROTERIXBIO — Class II
20220518
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false po | Product: ProterixBio SARS-CoV-2 (RBD) IgG Antib...
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FDA Device Recall: ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried
2022-05-18
Class II — FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
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nppes
1 records
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