ORTHO

Basic Information

• Brand Name: ORTHO
• Primary DI: 10758750003754
• Version / Model: 718380
• Catalog Number: 718380
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Labeler DUNS: 068715424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-24
• Public Version: 3
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 605434b0-a392-4bd3-81ec-b44be5e08915

Device Description

ORTHO® Bovine Albumin Solution Polymerized Bovine Solution

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
DCF	ALBUMIN, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52708	Bovine serum albumin (BSA) immunohaematology reagent IVD	A substance or reactant that is a bovine serum albumin (BSA) solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by reducing the zeta potential of red blood cells.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750003754	GS1

Storage Conditions

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