FDA Product Code JJX: Single (specified) Analyte Controls (assayed And Unassayed)
Leading manufacturers include Roche Diagnostics, Siemens Healthcare Diagnostics, Inc. and Boehringer Mannheim Corp..
493
Total
493
Cleared
62d
Avg days
1976
Since
493 devices
Cleared
Jul 30, 2007
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
Inverness Medical Innovations, Inc.
Chemistry
49d
Cleared
Apr 18, 2007
SMS MULTI GLUCOSE CONTROL, MODEL 2120049
Medical Specialties Supply Co., Inc.
Chemistry
56d
Cleared
Apr 12, 2007
SMS GLUCOSE CONTROL, MODEL 2120061
Spectrum Medical Supply, Inc.
Chemistry
35d
Cleared
Apr 02, 2007
FASTPACK TOTAL PSA METHOD VERIFICATION KIT
Qualigen, Inc.
Immunology
185d
Cleared
Feb 01, 2007
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047
Liberty Healthcare Group, Inc.
Chemistry
35d
Cleared
Oct 13, 2006
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
Roche Diagnostics Corp.
Chemistry
14d
Cleared
Sep 29, 2006
VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
Maine Standards Co.
Chemistry
35d
Cleared
Jun 19, 2006
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
Drew Scientific , Ltd.
Chemistry
112d
Cleared
Apr 28, 2006
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
Liberty Healthcare Group, Inc.
Chemistry
43d
Cleared
Apr 13, 2006
HEMOGLOBIN ALC CONTROL
Compass Bioscience
Chemistry
38d
Cleared
Mar 24, 2006
ALBU TROL, LOW, MODEL 108.001.002
Eurotrol B.V.
Chemistry
56d
Cleared
Mar 09, 2006
LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
Liberty Healthcare Group, Inc.
Chemistry
16d
Cleared
Mar 09, 2006
LIBERTY GLUCOSE CONTROL SOLUTION
Liberty Healthcare Group, Inc.
Chemistry
14d
Cleared
Feb 16, 2006
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
Inverness Medical Innovations, Inc.
Chemistry
29d
Cleared
Jan 26, 2006
OXICOM CONTROL
Bionostics, Inc.
Chemistry
56d
Cleared
Jan 26, 2006
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
Biokit, S.A.
Chemistry
22d
Cleared
Nov 30, 2005
LIBERTY GLUCOSE CONTROL, MODEL 2120031
Liberty Healthcare Group, Inc.
Chemistry
37d
Cleared
Nov 28, 2005
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
Roche Diagnostics
Chemistry
28d
Cleared
Nov 18, 2005
CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3
Cliniqa Corporation
Chemistry
51d
Cleared
Oct 04, 2005
HBA1C LINEARITY SET
Cone Bioproducts
Chemistry
71d
Cleared
May 16, 2005
IRMA TRUPOINT CREATININE CONTROL KIT
International Technidyne Corporation
Chemistry
27d
Cleared
May 13, 2005
RNA1C CONTROL FOR NYCOCARD HBA1C
Bionostics, Inc.
Chemistry
25d
Cleared
Mar 29, 2005
PREGNANCY-SKREEN
Biochemical Diagnostic, Inc.
Chemistry
48d
Cleared
Feb 25, 2005
RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER
Bionostics, Inc.
Chemistry
38d