Home › IBL International GmbH › Cortisol Saliva Luminescence Immunoassay
Cortisol Saliva Luminescence Immunoassay
IBL International GmbH · Model RE62119 · UDI-DI 04049325007734
NHG
Prescription
7
510(k) clearances
20
Adverse events
5
Recalls
5
Facilities
Description
Cortisol Saliva Luminescence Immunoassay Assay Kit - 10x96 Determinations
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2018-01-12 | Tecan US, Inc. | Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST corti |
| 2007-05-15 | Roche Diagnostics Corp. | The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples. |
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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.