MSVClass II

System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

21 CFR 866.5660 / Immunology

MSV is the FDA product code for System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), a class II device type, regulated under 21 CFR 866.5660. As of 2026-09-10, FDA records hold 46 510(k) clearances under this code, the most recent dated 2026-02-06, and one recall.

Classification record

Product code: MSV
Device name: System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Regulation: 21 CFR 866.5660
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 46
Ingested recalls: 1

Clearances, product code MSV

By decision year

46 clearances under product code MSV with a decision year between 1997 and 2026, 2002 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code MSV by decision year
Year	Clearances
1997	5
1998	5
1999	3
2000	4
2001	4
2002	6
2003	5
2004	4
2006	1
2008	1
2009	1
2010	1
2012	1
2015	2
2017	1
2018	1
2026	1

Applicants with the most clearances

Product code MSV

Applicants holding the most 510(k) clearances under product code MSV
Applicant	Clearances
Corgenix, Inc.	8
Inova Diagnostics, Inc.	7
Pharmacia Deutschland GmbH	4
The Binding Site	4
Cheshire Diagnostics, Ltd.	3
Hemagen Diagnostics, Inc.	3
Hycor Biomedical	3
Immco Diagnostics, Inc.	3
Theratest Laboratories, Inc.	3
Diamedix Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order