Who else makes this device?

Name: Access 25(OH) Vitamin D Total
Brand: Access 25(OH) Vitamin D Total

Clinical Chemistry › Test SystemsSystem, Test, Vitamin D

Access 25(OH) Vitamin D Total

The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in…

Registry build 21.09.26

The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the DxI Access Immunoassay Analyzers. Results are to be used as an aid in the assessment of vitamin D sufficiency.

1manufacturer

3catalogue numbers in this listing

3510(k) clearances naming this product 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 Access 25(OH) Vitamin D Total
Listed by	Beckman Coulter, 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, Manufacturer, Exporter
Record published	2016-09-09
Record revised	2018-04-09 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Access 25(OH) Vitamin D Total
Catalogue number	Size	Status
A98856		In distribution
B24838		In distribution
C28646		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
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
Advia Centaur® VitD	Siemens Healthcare Diagnostics Inc	1

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
K223503	2023-01-19
K142373	2014-12-22
K142362	2014-12-19

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.