DBMClass II

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

21 CFR 866.5090 / Immunology

DBM is the FDA product code for Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control, a class II device type, regulated under 21 CFR 866.5090. As of 2026-09-10, FDA records hold 27 510(k) clearances under this code, the most recent dated 2018-07-13, and 2 recalls.

Classification record

Product code: DBM
Device name: Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation: 21 CFR 866.5090
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: 27
Ingested recalls: 2

Clearances, product code DBM

By decision year

27 clearances under product code DBM with a decision year between 1976 and 2018, 1980 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code DBM by decision year
Year	Clearances
1976	1
1977	1
1979	1
1980	3
1981	2
1983	2
1984	2
1992	1
1993	1
1994	1
1995	1
1996	1
1997	1
1998	1
2003	2
2005	1
2010	1
2015	1
2017	2
2018	1

Applicants with the most clearances

Product code DBM

Applicants holding the most 510(k) clearances under product code DBM
Applicant	Clearances
Elias U.S.A., Inc.	2
Inova Diagnostics, Inc.	2
Phadia AB	2
Zeus Scientific LLC	2
Bioware Products	1
Calbiochem	1
Calbiochem-Behring Corp.	1
Clinical Sciences, Inc.	1
David A. Fuccillo, Ph.D.	1
Euroimmun US Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order