FDA-Device2022-05-18Class II
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
PROTERIXBIO
Hazard
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).
Sold states
Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
Affected count
640 kits
Manufactured in
1 Fortune Dr, N/A, Billerica, MA, United States
Products
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1058-2022Don't want to check this manually?
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