Beckmancoulter

Basic Information

• Brand Name: Beckmancoulter
• Primary DI: 15099590200183
• Version / Model: A07704
• Catalog Number: A07704
• Company Name: IMMUNOTECH
• Labeler DUNS: 270264732
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-21
• Public Version: 1
• Public Version Date: 2020-01-29
• Public Version Status: New
• Public Device Record Key: 653ca66c-ecd2-42d4-86d6-55771d5a01f6

Device Description

7-AAD Viability Dye

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
LEE	Stains, Dye Solution	Hematology	864.1850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63094	Cell viability solution IVD	A solution containing a dye or stain [e.g. 7-amino-actinomycin D (7-AAD)] intended to be used in cell viability assays in which the binding of the dye to deoxyribonucleic acid (DNA) in cells enables differentiation between live and dead cells, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590200183	GS1

Storage Conditions

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