Who else makes this device?

Name: Elecsys Vitamin D Assay
Brand: Elecsys Vitamin D Assay

Clinical Chemistry › Test SystemsSystem, Test, Vitamin D

Elecsys Vitamin D Assay

Catalogue number 6506780160, listed by Roche Diagnostics Gmbh, Germany, under System, Test, Vitamin D. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

3510(k) clearances naming this product code

2recalls 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 Elecsys Vitamin D Assay
Listed by	Roche Diagnostics Gmbh, Germany
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, Manufacturer, Exporter
510(k)	K113546
Record published	2016-09-20
Record revised	2018-07-06 (version 3)

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 Elecsys Vitamin D Assay
Catalogue number	Size	Status
6506780160		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
K210901	2021-09-01
K162840	2017-02-08
K113546	2012-07-24

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. 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
2018-04-27	Class II	Under Investigation by firm	The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a conseq	3591 units	2020-05-11
2018-04-27	Class II	Under Investigation by firm	The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a conseq	347 units	2020-05-11

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.