FDA-Device2022-04-13Class II
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Hologic, Inc
Hazard
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Sold states
US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA
Affected count
2061
Manufactured in
10210 Genetic Center Dr, San Diego, CA, United States
Products
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0877-2022Don't want to check this manually?
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