FDA-Device2020-08-26Class II
Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.
Cytocell Ltd.
Hazard
A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
Sold states
Worldwide distribution - US Nationwide distribution and the country of Canada.
Affected count
62 units
Manufactured in
418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, United Kingdom
Products
Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2829-2020Don't want to check this manually?
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