N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
Clinical Chemistry · 21 CFR 862.1725
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
- Diasorin Inc.TerminatedApr 14, 2007
DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum o
Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
Z-0748-2007 · View FDA record ↗ - PerkinElmer Life and Analytical Sciences, Wallac, OYTerminatedUnknown
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood spe
The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
Z-1220-2018 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.Jun 10, 2011
K110274 · AUTODELFIA NEONATAL IRT KIT
- Wallac Oy, Subsidiary of PerkinelmerDec 16, 2010
K102419 · GSP NEONATAL IRT KIT (3306-001U)
- Nuclear Diagnostics, Inc.Dec 2, 1993
K932406 · NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
- Microbiological Research Corp.Apr 26, 1989
K883011 · MRI NEO-TRYP TRYPSIN RIA
- Microanalytic Research, Inc.May 29, 1986
K861097 · TRYPSIN RIA KIT
- Bd Becton Dickinson Vacutainer Systems PreanalyticAug 31, 1981
K811805 · TRYPIN (125I) RIA KIT
- Cis Radiopharmaceuticals, Inc.Nov 5, 1979
K791202 · RIA KIT FOR TRYPSIN