Home › DRG Instruments Gesellschaft mit beschränkter Haftung › Androstenedione ELISA

Androstenedione ELISA

DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-3265 · UDI-DI 04048474032659

CIZ Prescription

510(k) clearances

125

Adverse events

Recalls

Facilities

Description

The DRG Androstenedione ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Androstenedione in serum and EDTA plasma.

Recalls

Date	Firm	Reason
2014-06-09	Siemens Healthcare Diagnostics Inc.	The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
2013-12-20	Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi And
2013-12-20	Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi And
2004-07-15	Diasorin Inc.	Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
2004-05-25	Diasorin Inc.	Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gel

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 key Read the docs

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.