VITROS

Basic Information

• Brand Name: VITROS
• Primary DI: 10758750030163
• Version / Model: 6842957
• Catalog Number: 6842957
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Labeler DUNS: 623873044
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-16
• Public Version: 3
• Public Version Date: 2023-08-30
• Public Version Status: Update
• Public Device Record Key: 417d22fe-7e91-4b0b-8fc0-314437b3e398

Device Description

VITROS Chemistry Products HCY 2 Performance Verifier I, II, III

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53749	Homocysteine IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of homocysteine in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750030163	GS1
Package	20758750030160	GS1	Case	60	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius