Anti-C3b,-C3d (Murine Monoclonal) Gamma-clone

Basic Information

• Brand Name: Anti-C3b,-C3d (Murine Monoclonal) Gamma-clone
• Primary DI: 10888234000402
• Version / Model: 0004068
• Catalog Number: 0004068
• Company Name: IMMUCOR, INC.
• Labeler DUNS: 061446282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b63a2a93-aa01-4ec0-886b-a10e29422d56

Device Description

This reagent is used in direct antiglobulin tests where the detection of C3 (as C3b or C3d) is required. This product configuration is a single vial.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
52721	Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody	One or multiple immunoglobulins capable of binding to C3b and/or C3d complement components fixed to red blood cells, and intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by complement C3b and/or C3d, using an agglutination technique.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234000402	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 10 Degrees Celsius