DIF · Class I · 21 CFR 862.3280

FDA Product Code DIF: Drug Mixture Control Materials

Leading manufacturers include Bio-Rad, Roche Diagnostic Systems, Inc. and Syva Co..

202
Total
202
Cleared
52d
Avg days
1978
Since
202 devices
49–72 of 202
Cleared May 30, 1997
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
K971691
Bio-Rad
Toxicology · 23d
Cleared May 21, 1997
SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
K971534
Beckman
Toxicology · 23d
Cleared Apr 08, 1997
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)
K971058
Medical Analysis Systems, Inc.
Chemistry · 15d
Cleared Mar 10, 1997
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
K970666
Bio-Rad
Chemistry · 14d
Cleared Feb 04, 1997
DE-TOX CONTROL 1 AND DE-TOX CONTROL 19
K964771
Dyna-Tek Industries
Toxicology · 69d
Cleared Jan 17, 1997
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
K965157
Boehringer Mannheim Corp.
Toxicology · 25d
Cleared Nov 25, 1996
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
K964422
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Jun 26, 1996
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
K962165
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jun 03, 1996
U-DOA CONTROLS
K961724
Medical Diagnostic Technologies, Inc.
Toxicology · 31d
Cleared Mar 22, 1996
DOCUMENT TDM ULTRA ASSAYED CONTROL
K960244
Casco Standards
Chemistry · 66d
Cleared Feb 05, 1996
LYPHOCHEK BENZO/TCA CONTROL-SET B
K955153
Bio-Rad
Toxicology · 84d
Cleared Dec 20, 1995
DOCUMENT TDM ULTRA UNASSAYED CONTROL
K955155
Casco Standards
Chemistry · 37d
Cleared Dec 13, 1995
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
K954799
Roche Diagnostic Systems, Inc.
Toxicology · 56d
Cleared Nov 20, 1995
OPUS TDM CONTROLS
K954291
Behring Diagnostics, Inc.
Toxicology · 67d
Cleared Oct 11, 1995
TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL
K954322
Medical Analysis Systems, Inc.
Toxicology · 26d
Cleared Sep 20, 1995
ABUSCREEN ONLINE CONTROLS
K953739
Roche Diagnostic Systems, Inc.
Toxicology · 44d
Cleared Sep 20, 1995
ABUSCREEN ONLINE DRUG FREE URINE
K953845
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Jun 23, 1995
DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL
K952412
Dupont Medical Products
Toxicology · 31d
Cleared Jun 01, 1995
IMMUNOASSAY DRUGS OF ABUSE CONTROLS
K952056
Medi-Tech, Inc.
Toxicology · 30d
Cleared Apr 13, 1995
MULTI-DRUG CONTROL SET
K951135
Microgenics Corp.
Chemistry · 31d
Cleared Feb 22, 1995
DRUGS OF ABUSE CONTROLS
K950138
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 40d
Cleared Jan 25, 1995
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999
Roche Diagnostic Systems, Inc.
Toxicology · 187d
Cleared Dec 09, 1994
ABUSCREEN ONLINE CONTROLS
K945194
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Oct 06, 1994
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
K942551
Medi-Tech, Inc.
Toxicology · 128d