MRG · Class II · 21 CFR 862.1825

FDA Product Code MRG: System, Test, Vitamin D

Leading manufacturers include Immunodiagnostic Systems , Ltd., DiaSorin, Inc. and Diazyme Laboratories.

46
Total
46
Cleared
182d
Avg days
1996
Since
46 devices
25–46 of 46
Cleared Jul 17, 2013
25-OH VITAMIN D ELISA
K123660
Euroimmun US
Chemistry · 231d
Cleared Jul 15, 2013
25OH VITAMIN D TOTAL ELISA TEST
K123364
Diasource Immunoassays, S.A.
Chemistry · 256d
Cleared Jul 03, 2013
FASTPACK VITAMIN D
K123983
Qualigen, Inc.
Chemistry · 189d
Cleared Jun 18, 2013
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D
K123253
Immunodiagnostic Systems , Ltd.
Chemistry · 244d
Cleared Feb 15, 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
K121608
Ortho-Clinical Diagnostics, Inc.
Chemistry · 259d
Cleared Feb 08, 2013
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
K123131
Tosoh Bioscience, Inc.
Chemistry · 127d
Cleared Nov 28, 2012
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
K122420
Diazyme Laboratories
Chemistry · 111d
Cleared Jul 24, 2012
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
K113546
Roche Diagnostics
Chemistry · 236d
Cleared Jan 20, 2012
LIAISON 25 OH VITAMIN D TOTAL ASSAY
K112725
DiaSorin, Inc.
Chemistry · 122d
Cleared Nov 23, 2011
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
K110619
Biokit, S.A.
Chemistry · 265d
Cleared Oct 14, 2011
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
K110586
Siemens Healthcare Diagnostics, Inc.
Chemistry · 227d
Cleared Jan 14, 2011
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
K102432
Diazyme Laboratories
Chemistry · 141d
Cleared Oct 01, 2007
LIAISON 25 OH VITAMIN D TOTAL
K071480
DiaSorin, Inc.
Chemistry · 125d
Cleared Jul 06, 2005
1,25-DIHYDROXY VITAMIN D EIA
K051110
Immunodiagnostic Systems , Ltd.
Chemistry · 65d
Cleared Dec 01, 2004
GAMMA-B 1,25-DIHYDROXY VITAMIN D
K042519
Immunodiagnostic Systems , Ltd.
Chemistry · 76d
Cleared Feb 12, 2004
LIAISON 25 OH VITAMIN D
K032844
DiaSorin, Inc.
Chemistry · 154d
Cleared May 10, 2002
OCTEIA 25-HYDROXY VITAMIN D
K021163
Immunodiagnostic Systems , Ltd.
Chemistry · 29d
Cleared Mar 26, 2002
1,25-DIHYDROXYVITAMIN D125I RIA
K014030
DiaSorin, Inc.
Chemistry · 110d
Cleared Sep 17, 1999
GAMMA-B 25-HYDROXY VITAMIN D RIA
K991998
Immunodiagnostic Systems , Ltd.
Chemistry · 95d
Cleared Sep 25, 1996
INCSTAR 25-HYDROXYVITMIN D 1251 RIA
K953567
Incstar Corp.
Chemistry · 422d