Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine
Clinical Chemistry · 21 CFR 862.1555
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Product problems
Reported product problem codes, most common first
No data available.
No trend to chart.
Recalls
2 recall events for this product code
- PerkinelmerTerminatedJan 16, 2013
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Z-0686-2013 · View FDA record ↗ - Bio-Rad Laboratories IncTerminatedMar 4, 2011
Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number 532-5035, included in 532-5036, 532-5037 and 532-5
Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.
Z-1562-2011 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
15 clearances for this product code
- Perkinelmer Life SciencesOct 28, 2002
K021541 · NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
- Micromass, Inc.Mar 19, 2001
K003584 · NEOLYNX SCREENING APPLICATION MANAGER
- Quantase , Ltd.Jun 19, 2000
K000754 · QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
- Quantase , Ltd.Feb 16, 1999
K984463 · QUANTASE PHE/GAL SCREENING ASSAY
- Wallac, Inc.Feb 2, 1999
K982307 · WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
- Neometrics, Inc.Dec 5, 1997
K974047 · ACCUWELL PHENYLALANINE ASSAY
- Bio-RadOct 1, 1996
K963040 · MANUAL PHENYLALANINE TEST
- Bio-RadAug 16, 1996
K960437 · RADIAS PHENYLALANINE TEST