VITROS

Basic Information

• Brand Name: VITROS
• Primary DI: 10758750034581
• Version / Model: 6199976
• Catalog Number: 6199976
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Labeler DUNS: 623873044
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-08
• Public Version: 1
• Public Version Date: 2021-11-16
• Public Version Status: New
• Public Device Record Key: 6d58235d-34f5-446a-9ef6-5bd6d9747e63

Device Description

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators

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

GMDN Terms

Code	Name	Definition	Implantable	Status
64865	SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials 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) in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750034581	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not refreeze
• Type: Storage Environment Temperature
• Temperature Range: -20 – -20 Degrees Celsius