VITROS

Basic Information

• Brand Name: VITROS
• Primary DI: 10758750004546
• Version / Model: 8209074
• Catalog Number: 8209074
• Company Name: ORTHO CLINICAL DIAGNOSTICS
• Labeler DUNS: 215865786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-26
• Public Version: 4
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 68da52e0-bab3-4321-ac84-f99039b21a27

Device Description

VITROS Immunodiagnostic Products Rubella IgG 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: 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
LFX	ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA	Microbiology	866.3510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60990	Rubella virus immunoglobulin G (IgG) 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 immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750004546	GS1

Storage Conditions

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