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Panels › Clinical Toxicology › Product code DIF · Class 1

Drug Mixture Control Materials

Regulation 862.3280

0510(k)s in 12 months (202 all time)

0recalls in 12 months (10 all time)

9recalls that name a 510(k)

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Top companies in DIF

Company	510(k)s	Recalls
Bio-Rad	31	0
Roche Diagnostic Systems, Inc.	14	0
Medical Analysis Systems, Inc.	13	0
Syva Co.	13	0
Utak Laboratories, Inc.	13	0
Ortho-Clinical Diagnostics, Inc.	1	5
Bio-Rad Laboratories	5	0
Quantimetrix Corp.	5	0
Biosite Incorporated	4	0
Fisher Scientific Co., LLC	4	0

Date	Firm and product	Code	Linked 510(k)
Nov 30, 2021	MEDLINE INDUSTRIES, LP - Northfield Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 Terminated	DIF	None listed
Apr 9, 2019	QUIDEL CARDIOVASCULAR INC Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com Terminated	DIF	K060788
Sep 22, 2017	Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic Terminated	DIF	K062077 K062165
Sep 22, 2017	Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic Terminated	DIF	K062077 K062165
Sep 22, 2017	Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic Terminated	DIF	K062077 K062165
Sep 22, 2017	Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic Terminated	DIF	K062077 K062165
Sep 22, 2017	Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic Terminated	DIF	K062077 K062165
Oct 23, 2013	Alere San Diego, Inc. Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each Terminated	DIF	K060788
Jan 23, 2012	Lin-Zhi International Inc Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 Multi-Analyte Urine Drug of Drug Abuse (DAU) Cont Terminated	DIF	K051088
Sep 14, 2005	Abbott Laboratories MPG XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA Terminated	DIF	K873183

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