VITROS

Basic Information

• Brand Name: VITROS
• Primary DI: 10758750001545
• Version / Model: 6801863
• Catalog Number: 6801863
• Company Name: ORTHO CLINICAL DIAGNOSTICS
• Labeler DUNS: 215865786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-08
• Public Version: 2
• Public Version Date: 2023-07-20
• Public Version Status: Update
• Public Device Record Key: 3cb5f96c-3204-4cb3-b0d2-36cc2958197d

Device Description

VITROS Immunodiagnostic Products Anti-HIV 1 + 2 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: 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
OHQ	Multi-analyte controls unassayed	Clinical Chemistry	862.1660	1
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48456	HIV1/HIV2 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 antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750001545	GS1
Package	20758750001542	GS1	Case	30	In Commercial Distribution

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: May be stored frozen, avoid repeated freeze-thaw cycles
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius