VITROS

Basic Information

• Brand Name: VITROS
• Primary DI: 10758750033409
• Version / Model: 6199924
• Catalog Number: 6199924
• Company Name: ORTHO CLINICAL DIAGNOSTICS
• Labeler DUNS: 215865786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-22
• Public Version: 2
• Public Version Date: 2024-01-19
• Public Version Status: Update
• Public Device Record Key: 5fad91e9-8b8e-4573-8ee4-2fe07f18ca68

Device Description

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

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: Yes
• 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
QKO	Reagent, coronavirus serological	Unknown		N
QVP	SARS-CoV-2 serology test	Microbiology	866.3983	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64868	SARS-CoV-2 total antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to 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
Primary	10758750033409	GS1
Package	20758750033406	GS1	Case	30	In Commercial Distribution

Storage Conditions

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