Who else makes this device?

Name: Fluoro-CheckTM Vitamin D
Brand: Fluoro-CheckTM Vitamin D

Clinical Chemistry › Test SystemsSystem, Test, Vitamin D

Fluoro-CheckTM Vitamin D

An in vitro diagnostic test for the determination of vitamin D in human serum and plasma specimen.

Registry build 21.09.26

1manufacturer

1catalogue number

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 Fluoro-CheckTM Vitamin D
Listed by	Nano-Ditech Corporation, United States
FDA product code	MRG
Device type	System, Test, Vitamin D
Device class	Class 2
Regulation	21 CFR 862.1825
Establishment	Repacker / relabeller, Manufacturer, Exporter
Record published	2019-05-24
Record revised	2023-06-29 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for Fluoro-CheckTM Vitamin D
Catalogue number	Size	Per pack	Status
TF8148		20	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

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.