FDA-Device2020-06-17Class II
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Biocare Medical, LLC
Hazard
Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.
Sold states
US: TX, MA, TN, MO, IN
Affected count
8
Manufactured in
60 Berry Dr, N/A, Pacheco, CA, United States
Products
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2291-2020Don't want to check this manually?
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