Home › Device types › JNO
N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
FDA product code JNO · Class 1 · Clinical Chemistry
8
Registered devices
0
Adverse events
2
Recalls
7
510(k) clearances
Devices with this code
TRYPS-US — CISBIO BIOASSAYSAutoDELFIA Neonatal IRT kit — Wallac OyMP Biomedicals LLC — Mp Biomedicals, LLCTrypsin-RIA — Diasource Immunoassays S.A. SAPancreatic Elastase ELISA — Seramun Diagnostica GmbHMP Biomedicals LLC — Mp Biomedicals, LLCGSP Neonatal IRT kit — Wallac OyAutoDELFIA Neonatal IRT kit — Wallac Oy
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-09-25 | PerkinElmer Life and Analytical Sciences, Wallac, OY | The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values |
| 2007-02-15 | Diasorin Inc. | Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay) |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.