Who else makes this device?

Name: Vitros
Brand: Vitros

Vitros · Ldl & Vldl Precipitation, Hdl → Clinical Chemistry

3manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LBR
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28
Hangzhou Lysun Biotechnology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	22

Record

Regulatory record for Vitros
Listed by	Ortho-Clinical Diagnostics, Inc., United States
FDA product code	LBR
Device type	Ldl & Vldl Precipitation, Hdl
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	2023-04-26 (version 2)

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	Special storage condition: Can also store 2-8 for up to 6m; Storage environment temperature -18 to -18 °C
Packaging	Case of 30

Catalogue Numbers

Catalogue numbers for Vitros
Catalogue number	Size	Status
1669829		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pointe Scientific, Inc.	Horiba Instruments Incorporated	11
Synermed®	Infrared Laboratory Systems LLC	4
LDL-Cholesterol Gen.3	Roche Diagnostics Gmbh	3
L-Type HDL-C Reagent 2	Fujifilm Wako Pure Chemical Corporation	2
Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix	Teco Diagnostics	2
N-geneous LDL Cholesterol Reagent (R1)	Sekisui Diagnostics, LLC	2
N-geneous LDL Cholesterol Reagent (R2)	Sekisui Diagnostics, LLC	2
PTS Panels® HDL Cholesterol Test Strips	Polymer Technology Systems	2
Teco Diagnostics HDL Cholesterol Reagent Set	Teco Diagnostics	2
CardioChek	Henry Schein, Inc.	2
L-Type HDL-C Reagent 1	Fujifilm Wako Pure Chemical Corporation	2
Carolina Liquid Chemistries Corp.® CLC720 HDL RGT KIT Product No. ST616	Carolina Liquid Chemistries	1

Showing 12 of 47. All products under Ldl & Vldl Precipitation, Hdl

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K012593	2001-08-30
K984303	1999-01-28

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