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Progesterone (17-a-OH Progesterone)

DRG Instruments Gesellschaft mit beschränkter Haftung · Model HYE-5333 · UDI-DI 04048474053333

JLX Prescription
10
510(k) clearances
7
Adverse events
3
Recalls
22
Facilities

Description

The DRG:Hybrid-XL 17-OH Progesterone is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-a-OH Progesterone (17-OH Progesterone or 17OHP) in serum and plasma.

Recalls

DateFirmReason
2024-09-13DRG 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
2023-04-05Siemens 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
2023-04-05Siemens 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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Data 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.