FDA-Device2021-08-25Class II
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Cytocell Ltd.
Hazard
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Sold states
US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
Affected count
23 units
Manufactured in
418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, United Kingdom
Products
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2323-2021Don't want to check this manually?
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