VITROS

Basic Information

• Brand Name: VITROS
• Primary DI: 10758750001323
• Version / Model: 6801758
• Catalog Number: 6801758
• 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: af5a9715-9533-4fbc-9eec-3b49467c1f6c

Device Description

VITROS Immunodiagnostic Products CA 15-3 Reagent Pack

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
MOI	SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60975	Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, 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	10758750001323	GS1
Package	20758750001320	GS1	Case	30	In Commercial Distribution

Storage Conditions

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