FDA-Device2013-01-23Class II
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Perkinelmer
Hazard
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Sold states
Nationwide Distribution.
Affected count
3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit)
Manufactured in
940 Winter Street, N/A, Waltham, MA, United States
Products
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0688-2013Don't want to check this manually?
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