MSV — System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Class II
FDA Device Classification
Classification Details
- Product Code
- MSV
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243979 | inova diagnostics | Aptiva APS IgA Reagent | February 6, 2026 |
| K181329 | phadia | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | June 25, 2018 |
| K162788 | immco diagnostics | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody | June 19, 2017 |
| K152875 | inova diagnostics | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar | December 21, 2015 |
| K141274 | inova diagnostics | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTRO | February 13, 2015 |
| K112414 | phadia us | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY | June 22, 2012 |
| K091556 | instrumentation laboratory | HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS | May 21, 2010 |
| K092757 | thera-test laboratories | THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR | October 9, 2009 |
| K072032 | corgenix | IGG ANTI-ATHEROX TEST KIT | April 4, 2008 |
| K062217 | aesku | AESKULSKA BETA2-GLYCO-A | December 13, 2006 |
| K040451 | pharmacia deutschland | VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 | May 11, 2004 |
| K040450 | pharmacia deutschland | VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 | May 11, 2004 |
| K040452 | pharmacia deutschland | VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 | May 11, 2004 |
| K040449 | pharmacia deutschland | VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 | May 11, 2004 |
| K030701 | immco diagnostics | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA | September 9, 2003 |
| K030702 | immco diagnostics | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA | September 9, 2003 |
| K031208 | corgenix | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 | July 7, 2003 |
| K031177 | axis-shield diagnostics | DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M | June 19, 2003 |
| K030397 | hycor biomedical | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA | March 21, 2003 |
| K022945 | hycor biomedical | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA | December 18, 2002 |