FDA-Device2014-01-22Class II
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
Lab Vision Corporation
Hazard
Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
Sold states
Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
Affected count
5
Manufactured in
46117 Landing Pkwy, Fremont, CA, United States
Products
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0775-2014Don't want to check this manually?
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