VITROS

Basic Information

• Brand Name: VITROS
• Primary DI: 10758750033638
• Version / Model: 6199954
• Catalog Number: 6199954
• Company Name: ORTHO CLINICAL DIAGNOSTICS
• Labeler DUNS: 215865786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-22
• Public Version: 1
• Public Version Date: 2023-11-30
• Public Version Status: New
• Public Device Record Key: 81de111c-7b42-46d4-954b-8160abc4d84e

Device Description

VITROS Immunodiagnostic Products Anti-SARS-COV-2 Total Calibrator

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
QVP	SARS-CoV-2 serology test	Microbiology	866.3983	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64866	SARS-CoV-2 total antibody IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of total antibodies severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20758750033635	GS1	Case	30	In Commercial Distribution
Primary	10758750033638	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN210040	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not refreeze
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius