Who else makes this device?

Name: Vitros
Brand: Vitros

Vitros · System, Test, Low Density, Lipoprotein → Clinical Chemistry

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Shandong (1), Guangxi (1), Hebei (1).

Chinese manufacturers registered for FDA product code MRR
Manufacturer	City	Province	Registered as	Device types
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28
Shijiazhuang Hipro Biotechnology Co., Ltd.	Shijiazhuang	Hebei	Manufacturer	22

Record

Regulatory record for Vitros
Listed by	Ortho-Clinical Diagnostics, Inc., United States
FDA product code	MRR
Device type	System, Test, Low Density, Lipoprotein
Device class	Class 1
Regulation	21 CFR 862.1475
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2020-04-18
Record revised	2023-07-06 (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
Storage	Storage environment temperature 2 to 8 °C; Special storage condition: Protect from light
Packaging	Case of 36

Catalogue Numbers

Catalogue numbers for Vitros
Catalogue number	Size	Status
6801728		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Biobase	Biobase Biodustry(Shandong)Co., Ltd.	19
Carolina Liquid Chemistries Corp.® LDL Cholesterol Direct Reagent KIT DT661	Carolina Liquid Chemistries	4
Pointe Scientific, Inc.	Horiba Instruments Incorporated	3
Direct LDL-Cholesterol (LDL)	Randox Laboratories Limited	3
Pointe autoLDL Cholesterol Reagent	Horiba Instruments Incorporated	2
N-geneous LDL-ST Cholesterol Reagent (R1)	Sekisui Diagnostics, LLC	2
Mercodia Oxidized LDL Elisa	Mercodia AB	2
ACE	Alfa Wassermann	2
N-geneous LDL-ST Cholesterol Reagent (R2)	Sekisui Diagnostics, LLC	2
Advia® Chemistry Direct LDL Cholesterol Reagents	Siemens Healthcare Diagnostics Inc	1
MedTest Dx, Inc. autoLDL	Medtest DX	1
Pointe Scientific, Inc. autoLDL Cholesterol	Horiba Instruments Incorporated	1

Showing 12 of 26. All products under System, Test, Low Density, Lipoprotein

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K041720	2004-08-25

Recalls

1 of these is 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
2018-10-08	Class II	Under Investigation by firm	VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results	5850 units	2022-10-13

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.

Vitros