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)
Top companies in MRG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Vitamin D2 and D3 Test Open, Classified |
MRG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Vitamin D-Test Open, Classified |
MRG | None listed |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 Terminated |
MRG | K153375 |
| Sep 11, 2018 | R & D Systems, Inc. R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 Terminated |
MRG | K123364 |
| Apr 27, 2018 | Roche 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 |
MRG | K162840 |
| Apr 27, 2018 | Roche 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 |
MRG | K162840 |
| Jul 7, 2017 | Qualigen Inc Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068
Vitamin D immunoassay kit Terminated |
MRG | K123983 |
| Oct 5, 2016 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Vitamin D Total Assay
SMN SMN 10699533 (500 test) Terminated |
MRG | K110586 |
| Oct 5, 2016 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Vitamin D Total Assay
SMN 10699201 (100 test) Terminated |
MRG | K110586 |
| May 23, 2014 | Siemens 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 |
MRG | K110586 |
| May 23, 2014 | Siemens 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 |
MRG | K110586 |
| May 23, 2014 | Siemens 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 |
MRG | K110586 |
| Dec 19, 2013 | Qualigen 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 |
MRG | K123983 |
| Apr 15, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021.
For use in the quantitative determination of Vit D. Terminated |
MRG | None listed |
| Apr 15, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994.
For use in the quantitative determination of Vit D. Terminated |
MRG | None listed |
| Jan 23, 2013 | Abbott 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 |
MRG | K110619 |
| Jan 18, 2013 | IDS (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 |
MRG | K021163 |
| Mar 21, 2012 | Siemens 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 |
MRG | K110586 |
| Oct 24, 2008 | Immunodiagnostics 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 |
MRG | K021163 |
| May 7, 2008 | Diasorin Inc. LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082 Terminated |
MRG | K032844 |
| Sep 20, 2007 | Diasorin Inc. 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Terminated |
MRG | K953567 |
| Apr 3, 2007 | Diasorin 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 |
MRG | K014030 |
| Mar 18, 2005 | Diasorin Inc. Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668 Terminated |
MRG | K032844 |
| Mar 18, 2005 | Diasorin Inc. LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E. Terminated |
MRG | K032844 |
| Feb 24, 2005 | Nichols Institute Diagnostics Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033. Terminated |
MRG | K012367 |
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