FDA-Device2013-01-23Class II
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening ne
Perkinelmer
Hazard
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Sold states
Nationwide Distribution.
Affected count
819 kits (10 plates/kit)
Manufactured in
940 Winter Street, N/A, Waltham, MA, United States
Products
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0687-2013Don't want to check this manually?
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