Vysis

Basic Information

• Brand Name: Vysis
• Primary DI: 00884999000735
• Version / Model: 01N31-005
• Catalog Number: 01N31-005
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-20
• Public Version: 5
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: c993814c-6c97-4dec-a354-a06ac71d3092

Device Description

Vysis Paraffin Pretreatment IV & Post-Hybridization Wash Buffer Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWE	Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60120	Nucleic acid hybridization detection IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [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	00884999000735	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P110012	001
P110012	002
P110012	003
P110012	004
P110012	005
P110012	006
P110012	007
P110012	008
P110012	009

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Upon receipt store Protease IV at -30 to -10oC
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius