FDA-Device2017-06-07Class II
Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Cell Marque Corporation
Hazard
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
Sold states
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
Manufactured in
6600 Sierra College Blvd, Rocklin, CA, United States
Products
Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2200-2017Don't want to check this manually?
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