Vysis

Basic Information

• Brand Name: Vysis
• Primary DI: 00884999027084
• Version / Model: 07J22-012
• Catalog Number: 07J22-012
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9d51783c-ffa5-49d4-a158-a23796f42378

Device Description

CEP 12 SpectrumOrange

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
KIR	CELLS, ANIMAL AND HUMAN, CULTURED	Hematology	864.2280	1
OVQ	Chronic lymphocytic leukemia fish probe kit	Immunology	866.6040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61464	Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe	A defined piece of single-stranded nucleic acid which is used to identify specific complementary sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict chronic lymphocytic leukaemia (CLL) based on changes at the gene or chromosomal level, which may involve genetic markers on chromosomes 11, 12, 13 and 17.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999027084	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K962873	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store unopened probe kit protected from light and humidity. Store 20X SSC salts and NP - 40 at room temperature. Store Slides in a sealed container with desiccant protected from humidity.
• Type: Storage Environment Temperature
• Temperature Range: -20 – -20 Degrees Celsius