DISClass II

Enzyme Immunoassay, Barbiturate

21 CFR 862.3150 / Clinical Toxicology

DIS is the FDA product code for Enzyme Immunoassay, Barbiturate, a class II device type, regulated under 21 CFR 862.3150. As of 2026-09-10, FDA records hold 100 510(k) clearances under this code, the most recent dated 2016-10-14, and 7 recalls.

Classification record

Product code: DIS
Device name: Enzyme Immunoassay, Barbiturate
Regulation: 21 CFR 862.3150
Device class: Class II
Review panel: Clinical Toxicology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 100
Ingested recalls: 7

Clearances, product code DIS

By decision year

100 clearances under product code DIS with a decision year between 1979 and 2016, 1987 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code DIS by decision year
Year	Clearances
1979	1
1980	1
1981	1
1984	5
1987	8
1988	4
1989	4
1990	3
1992	4
1993	4
1994	6
1995	4
1996	5
1997	1
1998	5
1999	7
2000	5
2001	8
2002	3
2003	3
2004	5
2005	2
2007	3
2011	2
2014	2
2015	3
2016	1

Applicants with the most clearances

Product code DIS

Applicants holding the most 510(k) clearances under product code DIS
Applicant	Clearances
Abbott Medical	7
Princeton BioMeditech Corp.	6
Roche Diagnostic Systems, Inc.	6
Syva Co.	6
MEDTOX Diagnostics, Inc.	4
Microgenics Corporation	4
Acon Laboratories, Inc.	3
Siemens Healthcare Diagnostics Inc.	3
Diagnostic Reagents, Inc.	3
E.I. Dupont de Nemours & Co., Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 73 companies shown, in name order