Vysis

Basic Information

• Brand Name: Vysis
• Primary DI: 00884999026254
• Version / Model: 07J06-001
• Catalog Number: 07J06-001
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: dc24ce08-7efb-4aa8-98ae-4134fe745f60

Device Description

Propidium Iodide Counterstain, 2 x 500 uL (400 ng/mL)

Device Characteristics

• Single Use: Yes
• 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
PPM	General purpose reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62512	DAPI solution IVD	A solution containing the fluorescent dye 4',6-Diamidino-2-phenylindole dihydrochloride (DAPI) intended to be used as a counterstain for the visualization of deoxyribonucleic acids (DNA) in assays performed on biological tissues or clinical specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999026254	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: -20 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from Sunlight