FDA-Device2021-02-17Class II
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
Cytocell Ltd.
Hazard
Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green.
Sold states
Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada.
Affected count
72
Manufactured in
418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, United Kingdom
Products
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1099-2021Don't want to check this manually?
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