VITROS

Basic Information

• Brand Name: VITROS
• Primary DI: 10758750004560
• Version / Model: 8221384
• Catalog Number: 8221384
• 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: 2
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 8934b0a8-6bb8-4e30-a6a0-4b5a99ed706a

Device Description

VITROS Chemistry Products PHBR Slides

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
DLZ	ENZYME IMMUNOASSAY, PHENOBARBITAL	Clinical Toxicology	862.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55417	Phenobarbital therapeutic drug monitoring IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the central nervous system drug phenobarbital in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750004560	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -18 – -18 Degrees Celsius