VITROS

Basic Information

• Brand Name: VITROS
• Primary DI: 10758750033577
• Version / Model: 6199944
• Catalog Number: 6199944
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Labeler DUNS: 623873044
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-22
• Public Version: 1
• Public Version Date: 2021-03-30
• Public Version Status: New
• Public Device Record Key: 2cb06821-5d9e-4f02-a872-efcdb7f998d2

Device Description

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Extraction Buffer

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
QKP	Coronavirus antigen detection test system.	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
62669	Clinical specimen extraction buffer IVD	A buffered solution intended to be used for the processing and preparation of a clinical specimen, for subsequent in vitro diagnostic testing, by extraction of specific target analytes present in the clinical specimen (e.g., proteins, antigens).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750033577	GS1

Storage Conditions

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