Vysis

Basic Information

• Brand Name: Vysis
• Primary DI: 00884999011700
• Version / Model: 05J38-030
• Catalog Number: 05J38-030
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: bfda0a79-c3de-4d21-885d-a07eb20d4382

Device Description

AneuVysion DNA Probe 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
OYU	Dna-probe kit, human chromosome	Immunology	866.4700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59949	Multiple congenital aneuploidy screening 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 one or multiple congenital aneuploidies, including (but not limited to) trisomy 13 (Pätau syndrome), trisomy 18 (Edwards syndrome), trisomy 21 (Down syndrome), and sex chromosome aneuploidies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999011700	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K010288	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store unopened kit protected from light and humidity. Store 20X SSC salts and NP - 40 at room temperature. Avoid kit components exposed to light, heat, or humidity.
• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius