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 Jul 07, 1997
PRECINORM TDM CONTROLS
K971060
Boehringer Mannheim Corp.
Chemistry · 105d
Cleared Jun 24, 1997
LYPHOCHEK REMEDI CONTROL
K972174
Bio-Rad
Toxicology · 15d
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 19, 1995
ELI URINE CONTROLS
K951817
Elsohly Labs, Inc.
Chemistry · 60d
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