MSV — System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Class II
FDA product code MSV covers "System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)", a Class II medical device regulated under 21 CFR 866.5660. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| 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 |
| K040450 | pharmacia deutschland | VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 | May 11, 2004 |
| K030702 | immco diagnostics | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA | September 9, 2003 |
| K030701 | immco diagnostics | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG 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 |