JJX · Class I · 21 CFR 862.1660

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
25–48 of 493
Cleared Nov 21, 2014
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
K143026
Aalto Scientific, Ltd.
Chemistry · 31d
Cleared Oct 30, 2014
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material
K142878
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Oct 29, 2014
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
K142811
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 29, 2014
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)
K142864
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Sep 05, 2014
ELECSYS ESTRADIOL III CALCHECK 5
K142127
Roche Diagnostics
Chemistry · 32d
Cleared Aug 19, 2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
K141772
Siemens Healthcare Diagnostics, Inc.
Microbiology · 49d
Cleared Jul 09, 2014
IMMULITE 2000
K141444
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Jun 24, 2014
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
K133816
Siemens Healthcare Diagnostics, Inc.
Immunology · 190d
Cleared May 01, 2014
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C
K140818
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Apr 01, 2014
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
K140541
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 31, 2014
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
K140505
Siemens Healthcare Diagnostics, Inc.
Chemistry · 32d
Cleared Mar 27, 2014
ELECSYS PRECICONTROL TS
K140534
Roche Diagnostics
Chemistry · 23d
Cleared Mar 10, 2014
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
K140267
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 05, 2014
IMMULITE 2000 DHEA-SO4
K140258
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Feb 05, 2014
VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
K133550
Maine Standards Company, LLC
Chemistry · 78d
Cleared Jan 17, 2014
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
K133197
Fujirebio Diagnostics,Inc.
Chemistry · 92d
Cleared Jan 14, 2014
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
K132739
Siemens Healthcare Diagnostics, Inc.
Immunology · 133d
Cleared Nov 22, 2013
ELECSYS CK-MB CALCHECK 5
K133284
Roche Diagnostics
Chemistry · 28d
Cleared Oct 30, 2013
IMMULITE 2000
K133122
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Oct 25, 2013
IMMULITE 2000
K133124
Siemens Healthcare Diagnostics, Inc.
Chemistry · 25d
Cleared Oct 24, 2013
RIGHTEST CONTROL SOLUTION
K133003
Bionime Corporation
Chemistry · 29d
Cleared Oct 22, 2013
IMMULITE 2000
K133128
Siemens Healthcare Diagnostics, Inc.
Chemistry · 22d
Cleared Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662
Siemens Healthcare Diagnostics, Inc.
Chemistry · 125d
Cleared Sep 20, 2013
IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL
K132391
Siemens Helathcare Diagnostics, Inc.
Immunology · 50d