System, Test, Vitamin D

FDA product code MRG · 37 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1825
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1996-09-25 – 2024-04-12

MRG 2024-04-12

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

Applicant Shenzhen New Industries Biomedical Engineering Co., Ltd.

K number K232587

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MRG 2023-09-22

ALFIS Vitamin D, ALFIS-3 Analyzer

Applicant Immunostics Inc.,

K number K221817

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MRG 2023-01-19

Access 25(OH) Vitamin D Total

Applicant Beckman Coulter, Inc.

K number K223503

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MRG 2021-09-01

Elecsys Vitamin D total III

Applicant Roche Diagnostics

K number K210901

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MRG 2020-05-29

ADVIA Centaur Vitamin D Total (VitD)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K200509

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MRG 2019-08-01

MAGLUMI 2000 25-OH Vitamin D

Applicant Shenzhen New Industries Biomedical Engineering Co., Ltd.

K number K191499

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MRG 2018-06-22

BioPlex 2200 25-OH Vitamin D Kit

Applicant Bio-Rad Laboratories

K number K180577

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MRG 2018-01-11

Diazyme EZ Vitamin D Assay

Applicant Diazyme Laboratories

K number K172992

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MRG 2017-03-16

LOCI Total Vitamin D Total Assay, LOCI VITD CAL

Applicant Siemens Healthcare Diagnostics

K number K162298

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MRG 2017-02-08

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5

Applicant Roche Diagnostics

K number K162840

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MRG 2017-01-12

FREND Vitamin D Test System

Applicant Nanoentek USA, Inc.

K number K162754

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MRG 2016-11-15

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set

Applicant Immunodiagnostic Systems , Ltd.

K number K161831

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MRG 2016-08-12

ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls

Applicant Abbott Laboratories

K number K153375

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MRG 2016-04-15

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

Applicant Fujirebio Diagnostics,Inc.

K number K153361

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MRG 2013-09-05

LIAISON 25 TOTAL-D

Applicant DiaSorin, Inc.

K number K132492

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MRG 2013-07-17

25-OH VITAMIN D ELISA

Applicant Euroimmun US

K number K123660

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MRG 2013-07-15

25OH VITAMIN D TOTAL ELISA TEST

Applicant Diasource Immunoassays, S.A.

K number K123364

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MRG 2013-07-03

FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS

Applicant Qualigen, Inc.

K number K123983

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MRG 2013-06-18

IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D

Applicant Immunodiagnostic Systems , Ltd.

K number K123253

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MRG 2013-02-15

VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K121608

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MRG 2013-02-08

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

Applicant Tosoh Bioscience, Inc.

K number K123131

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MRG 2012-11-28

DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA

Applicant Diazyme Laboratories

K number K122420

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MRG 2012-07-24

ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5

Applicant Roche Diagnostics

K number K113546

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MRG 2012-01-20

LIAISON 25 OH VITAMIN D TOTAL ASSAY

Applicant DiaSorin, Inc.

K number K112725

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MRG 2011-11-23

ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS

Applicant Biokit, S.A.

K number K110619

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MRG 2011-10-14

ADVIA CENTAUR VITAMIN D TOTAL ASSAY

Applicant Siemens Healthcare Diagnostics, Inc.

K number K110586

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MRG 2011-01-14

DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,

Applicant Diazyme Laboratories

K number K102432

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MRG 2010-06-25

IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET

Applicant Immunodiagnostic Systems, Inc.

K number K091849

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MRG 2008-05-07

ESA BIOSCIENCES INC. VITAMIN D HPLC TEST

Applicant Esa Biosciences, Inc.

K number K072536

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MRG 2007-10-01

LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602

Applicant DiaSorin, Inc.

K number K071480

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MRG 2005-07-06

1,25-DIHYDROXY VITAMIN D EIA

Applicant Immunodiagnostic Systems , Ltd.

K number K051110

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MRG 2004-12-01

GAMMA-B 1,25-DIHYDROXY VITAMIN D

Applicant Immunodiagnostic Systems , Ltd.

K number K042519

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MRG 2004-02-12

LIAISON 25 OH VITAMIN D

Applicant DiaSorin, Inc.

K number K032844

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MRG 2002-05-10

OCTEIA 25-HYDROXY VITAMIN D

Applicant Immunodiagnostic Systems , Ltd.

K number K021163

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MRG 2002-03-26

1,25-DIHYDROXYVITAMIN D125I RIA

Applicant DiaSorin, Inc.

K number K014030

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MRG 1999-09-17

GAMMA-B 25-HYDROXY VITAMIN D RIA

Applicant Immunodiagnostic Systems , Ltd.

K number K991998

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MRG 1996-09-25

INCSTAR 25-HYDROXYVITMIN D 1251 RIA

Applicant Incstar Corp.

K number K953567

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