FDA Device Intelligence
Home › Siemens Healthcare Diagnostics Products GmbH › N Antiserum to Human C1-Inhibitor

N Antiserum to Human C1-Inhibitor

Siemens Healthcare Diagnostics Products GmbH · Model 10446049 · UDI-DI 00842768007323

DBA
1
510(k) clearances
0
Adverse events
1
Recalls
5
Facilities

Description

Quantitative determination of C1 Inhibitor in human serum and plasma on BN Systems

Recalls

DateFirmReason
2023-02-01Quidel CorporationKits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

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 keyRead 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.