ClearanceBrief
Panels › Clinical Chemistry › Product code MRG · Class 2

System, Test, Vitamin D

Regulation 862.1825

0510(k)s in 12 months (46 all time)
2recalls in 12 months (25 all time)
21recalls that name a 510(k)
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Top companies in MRG

DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
Vitamin D2 and D3 Test
Open, Classified
MRGNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Vitamin D-Test
Open, Classified
MRGNone listed
Nov 21, 2018Abbott Ireland Diagnostics Division
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Terminated
MRGK153375
Sep 11, 2018R & D Systems, Inc.
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Terminated
MRGK123364
Apr 27, 2018Roche Diagnostics Corporation
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and
Terminated
MRGK162840
Apr 27, 2018Roche Diagnostics Corporation
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and
Terminated
MRGK162840
Jul 7, 2017Qualigen Inc
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Terminated
MRGK123983
Oct 5, 2016Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Vitamin D Total Assay SMN SMN 10699533 (500 test)
Terminated
MRGK110586
Oct 5, 2016Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test)
Terminated
MRGK110586
May 23, 2014Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA C
Terminated
MRGK110586
May 23, 2014Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Cen
Terminated
MRGK110586
May 23, 2014Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centa
Terminated
MRGK110586
Dec 19, 2013Qualigen Inc
FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determinatio
Terminated
MRGK123983
Apr 15, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
Terminated
MRGNone listed
Apr 15, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
Terminated
MRGNone listed
Jan 23, 2013Abbott Laboratories
Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.
Terminated
MRGK110619
Jan 18, 2013IDS (Immunodiagnostic Systems Ltd.)
25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) a
Terminated
MRGK021163
Mar 21, 2012Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin
Terminated
MRGK110586
Oct 24, 2008Immunodiagnostics Systems Inc
IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08;
Terminated
MRGK021163
May 7, 2008Diasorin Inc.
LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082
Terminated
MRGK032844
Sep 20, 2007Diasorin Inc.
25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.
Terminated
MRGK953567
Apr 3, 2007Diasorin Inc.
1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-DiaSorin, Stillwater, Minnesota 55082-0285, USA
Terminated
MRGK014030
Mar 18, 2005Diasorin Inc.
Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
Terminated
MRGK032844
Mar 18, 2005Diasorin Inc.
LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E.
Terminated
MRGK032844
Feb 24, 2005Nichols Institute Diagnostics
Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.
Terminated
MRGK012367

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