Home › DRG Instruments Gesellschaft mit beschränkter Haftung › Salivary 17-OH Progesterone ELISA
Salivary 17-OH Progesterone ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model SLV-3140 · UDI-DI 04048474031409
JLX
Prescription
1
510(k) clearances
7
Adverse events
3
Recalls
22
Facilities
Description
An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone in saliva.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-13 | DRG International, Inc. | The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to |
| 2023-04-05 | Siemens Healthcare Diagnostics, Inc. | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias |
| 2023-04-05 | Siemens Healthcare Diagnostics, Inc. | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias |
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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.