FDA Device Intelligence
Home › Bio-Rad Medical Diagnostics GmbH › IH-Titration Solution

IH-Titration Solution

Bio-Rad Medical Diagnostics GmbH · Model 813560100 · UDI-DI 07611969952205

KSG
10
510(k) clearances
11
Adverse events
1
Recalls
14
Facilities

Description

IH-Titration Solution is a dilution medium for the titer determination of antibodies in patient and donor samples for use with appropriate IH-Cards.

Recalls

DateFirmReason
2019-10-14Ortho Clinical Diagnostics IncPotential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7

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.