BIOCLONE

Basic Information

• Brand Name: BIOCLONE
• Primary DI: 10758750003471
• Version / Model: 716080
• Catalog Number: 716080
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Labeler DUNS: 068715424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-22
• Public Version: 5
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: 8b0b450c-e242-4b75-a7b2-325d1db314d5

Device Description

Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML

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

GMDN Terms

Code	Name	Definition	Implantable	Status
46949	Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination	A collection of immunoglobulins capable of binding to individual classes of human immunoglobulin and/or complement components fixed to red blood cell antigens, and intended to be used together in testing a clinical specimen to detect red blood cell sensitization by specific molecules, using an agglutination technique. The specific molecules intended to be detected may include immunoglobulin A (IgA), immunoglobulin G (IgG), immunoglobulin M (IgM), C3c, and/or C3d.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750003471	GS1

Storage Conditions

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