Who else makes this device?

Name: Dimension® EXL™ Total Vitamin D
Brand: Dimension® EXL™ Total Vitamin D

Clinical Chemistry › Test SystemsSystem, Test, Vitamin D

Dimension® EXL™ Total Vitamin D

Dimension EXL Total Vitamin D is a laboratory assay for measuring total 25-hydroxyvitamin D in human serum and plasma. It is used on compatible Dimension EXL analysers with a LOCI module to…

Registry build 21.09.26

Dimension EXL Total Vitamin D is a laboratory assay for measuring total 25-hydroxyvitamin D in human serum and plasma. It is used on compatible Dimension EXL analysers with a LOCI module to assess vitamin D sufficiency and measures both D2 and D3 forms.

A releasing reagent separates vitamin D from its binding proteins. Vitamin D then competes in an antibody-based reaction involving two types of synthetic beads. Light activation causes a chemiluminescent signal, which becomes weaker as the sample’s vitamin D concentration increases.

Listed Item

Dimension® EXL™ Total Vitamin D, 200 tests (4×50)

Samples and Measurement

The assay accepts serum, EDTA plasma and lithium-heparin plasma. Its measuring range is five to 150 nanograms per millilitre.

1manufacturer

1catalogue number

4510(k) clearances naming this product code

8recalls on this code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code MRG
Manufacturer	City	Province	Registered as	Device types
Shenzhen NEW Industries Biomedical Engineering Co., Ltd.	Shenzhen	Guangdong	Manufacturer	4

Record

Regulatory record for Dimension® EXL™ Total Vitamin D
Listed by	Siemens Healthcare Diagnostics Inc, United States
FDA product code	MRG
Device type	System, Test, Vitamin D
Device class	Class 2
Regulation	21 CFR 862.1825
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K162298
Record published	2018-12-23
Record revised	2021-11-18 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Dimension® EXL™ Total Vitamin D
Catalogue number	Size	Per pack	Status
10706480		4	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BioPlex 2200	Bio-Rad Laboratories Inc.	6
Access 25(OH) Vitamin D Total	Beckman Coulter, Inc.	3
Maglumi 25-OH Vitamin D	Shenzhen NEW Industries Biomedical Engineering Co., Ltd.	3
Architect	Abbott Medical	3
Atellica™ IM VitD	Siemens Healthcare Diagnostics Inc	2
1,25 Dihydroxy Vitamin D RIA	Immunodiagnostic Systems Ltd.	2
Maglumi 2000 25-OH Vitamin D	Shenzhen NEW Industries Biomedical Engineering Co., Ltd.	2
Alinity	Abbott Ireland	2
Architect	Abbott Ireland	2
Elecsys Vitamin D total II	Roche Diagnostics Gmbh	2
IDS-iSYS 25 VitDS	Immunodiagnostic Systems Ltd.	2
Elecsys Vitamin D total III	Roche Diagnostics Gmbh	2

Showing 12 of 50. All products under System, Test, Vitamin D

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K200509	2020-05-29
K162298	2017-03-16
K133156	2014-07-24
K110586	2011-10-14

Recalls

7 of these are Class II. Class II means a temporary or reversible health consequence. 2 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-10-05	Class II	Device Design	Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples	69781 kits	2019-08-29
2016-10-05	Class II	Device Design	Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples	37437 kits	2019-08-29
2014-04-10	Class II	Device Design	Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.	17,731 kits	2016-05-27
2014-04-10	Class II	Device Design	Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.	40,266 kits	2016-05-27
2014-04-10	Class II	Device Design	Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.	12,787 kits	2016-05-27
2013-03-13	Class II	No Marketing Application	Negative bias in patient samples for Vitamin D	4133	2015-03-05
2013-03-13	Class II	No Marketing Application	Negative bias in patient samples for Vitamin D	3871	2015-03-05
2012-02-16	Not classified	Nonconforming Material/Component	Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%.	442 units	2013-10-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.