Product code MSV— Immunology
AESKULSKA BETA2-GLYCO-A
- Classification name
- System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Total cleared
- 46
- First cleared
- Most recent
Market context for product code MSV
FDA has cleared devices under product code MSV between 1997 and 2026, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2018
- 2017
- 2015
- 2012
- 2010
- 2009
- 2008
- 2006
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
Top applicants under product code MSV
Recent clearances under product code MSV
- K243979 — Aptiva APS IgA Reagent
- K181329 — EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
- 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
- K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
- K141274 — QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
- K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
- K091556 — HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
- K092757 — THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
- K072032 — IGG ANTI-ATHEROX TEST KIT
- K062217 — AESKULSKA BETA2-GLYCO-A
- K040449 — VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
- K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
- K040451 — VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
- K040452 — VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
- K030701 — IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
- K030702 — IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
- K031208 — REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
- K031177 — DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
- K030397 — AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
- K022944 — AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
- K022945 — AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
- K021610 — QAB2A IGM ELISA KIT HRP
- K021611 — QAB2A IGG ELISA KIT HRP
- K020695 — QAB2A IGG ELISA KIT
- K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
- K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
- K013077 — REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
- K013079 — REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
- K013080 — REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
- K991801 — BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
- K991802 — BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
- K991803 — BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
- K991804 — BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
- K992224 — VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
- K992241 — VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
- K992243 — VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
- K982434 — REAADS IGA ANTI-B2GP 1 TEST KIT
- K982391 — REAADS IGG ANTI-B2GPI TEST KIT
- K982433 — REAADS IGM ANTI-B2GP1 TEST KIT
- K982879 — SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
- K980230 — QUANTA LITE B2 GPI SCREEN
- K972790 — THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR
- K973882 — EL-B2GP1SCR
- K973006 — QUANTA LITE B2 GPI IGA
- K973014 — QUANTA LITE B2GPI IGM
- K970551 — QUANTA LITE B2GPI IGG
Data sourced from openFDA. This site is unofficial and independent of the FDA.