Who else makes this device?

Name: Maglumi 25-OH Vitamin D
Brand: Maglumi 25-OH Vitamin D

Clinical Chemistry › Test SystemsSystem, Test, Vitamin D

Maglumi 25-OH Vitamin D

MAGLUMI 25-OH Vitamin D is a laboratory immunoassay that quantifies total 25-hydroxyvitamin D in human serum or K2EDTA plasma. It runs on compatible MAGLUMI automated immunoassay analyzers…

Registry build 21.09.26

MAGLUMI 25-OH Vitamin D is a laboratory immunoassay that quantifies total 25-hydroxyvitamin D in human serum or K2EDTA plasma. It runs on compatible MAGLUMI automated immunoassay analyzers and aids assessment of vitamin D sufficiency.

Antibody coated magnetic beads capture vitamin D from the sample. A second antibody labeled with ABEI forms a sandwich complex. After magnetic separation and washing, starter reagents produce light that is measured in proportion to the vitamin D concentration.

Kit Components

The reagent kit includes magnetic beads, buffer, labeled antibody, low and high calibrators and two control levels. The assay uses a two point calibration and a 10 microliter sample.

1manufacturer

3catalogue numbers in this listing

2510(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 Maglumi 25-OH Vitamin D
Listed by	Shenzhen NEW Industries Biomedical Engineering Co., Ltd., China
FDA product code	MRG
Device type	System, Test, Vitamin D
Device class	Class 2
Regulation	21 CFR 862.1825
Establishment	Manufacturer
510(k)	K232587
Record published	2026-05-15

Specifications

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

Catalogue Numbers

Catalogue numbers for Maglumi 25-OH Vitamin D
Catalogue number	Size	Status
130761601M		In distribution
130261601M		In distribution
130661601M		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
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
K232587	2024-04-12
K191499	2019-08-01

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.