System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Immunology · 21 CFR 866.5660
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
52 firms currently registered for this product code
Instrumentation Laboratory Spa
Roncello Lombardy, IT
Bio-rad Laboratories, Inc.
Hercules, CA, US
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Hemagen Diagnostics, Inc.
Baltimore, MD, US
Instrumentation Laboratory Co.
Bedford, MA, US
American Laboratory Products Company
Salem, NH, US
Phadia Ab
Uppsala, SE
Louisville Apl Diagnostics, Inc.
Texas City, TX, US
Inova Diagnostics, Inc.
SAN DIEGO, CA, US
Phadia Ab
UPPSALA, SE
Instrumentation Laboratory Co. - Devens
Devens, MA, US
Steris Schweiz Ag
Daniken Solothurn, CH
Corgenix, Inc.
BROOMFIELD, CO, US
Phadia Us Inc.
Portage, MI, US
510(k) clearances
46 clearances for this product code
- Inova Diagnostics, Inc.Feb 6, 2026
K243979 · Aptiva APS IgA Reagent
- Phadia ABJun 25, 2018
K181329 · EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
- Immco Diagnostics, Inc.Jun 19, 2017
K162788 · ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
- Inova Diagnostics, Inc.Dec 21, 2015
K152875 · QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
- Inova Diagnostics, Inc.Feb 13, 2015
K141274 · QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
- Phadia US, Inc.Jun 22, 2012
K112414 · ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
- Instrumentation Laboratory COMay 21, 2010
K091556 · HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
- Thera-Test Laboratories, Inc.Oct 9, 2009
K092757 · THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR