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Pancreatic Elastase ELISA
Seramun Diagnostica GmbH · Model G09040 · UDI-DI 04099466112248
7
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities
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 which may result in |
| 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) |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.