Vysis

Basic Information

• Brand Name: Vysis
• Primary DI: 00884999012004
• Version / Model: 05J51-001
• Catalog Number: 05J51-001
• 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: 3
• Public Version Date: 2018-10-05
• Public Version Status: Update
• Public Device Record Key: 68c18c7c-c344-478f-86e7-48c3a6465778

Device Description

Vysis LSI CDKN2A SpectrumOrange/CEP 9 SpectrumGreen Probes

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
MVU	REAGENTS,SPECIFIC,ANALYTE	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61199	Nucleic acid hybridization detection IVD, probe	A defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999012004	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark
• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius