Mono Mo A-Hu CD34 Class III/APC Cl BIRMA-K3

Basic Information

• Brand Name: Mono Mo A-Hu CD34 Class III/APC Cl BIRMA-K3
• Primary DI: 05700572007081
• Version / Model: C7238
• Company Name: AGILENT TECHNOLOGIES SINGAPORE PTE LTD
• Labeler DUNS: 894671143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-17
• Public Version: 2
• Public Version Date: 2020-12-07
• Public Version Status: Update
• Public Device Record Key: fca5bb2b-c3c8-4301-9be2-5a88dd49b7d7

Device Description

Monoclonal Mouse Anti-Human CD34 Class III/APC Clone BIRMA-K3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
MVU	Reagents, specific, analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56974	CD34 cell marker IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD34 cell marker in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700572007081	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	0.5	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius