Vysis

Basic Information

• Brand Name: Vysis
• Primary DI: 00884999027046
• Version / Model: 07J21-002
• Catalog Number: 07J21-002
• 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: e8f374b8-966a-49f4-8c39-e54e95bdc048

Device Description

ProbeChek Positive Control 10% Trisomy 8/12

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
OVQ	Chronic lymphocytic leukemia fish probe kit	Immunology	866.6040	2
OYU	Dna-probe kit, human chromosome	Immunology	866.4700	2
KIR	CELLS, ANIMAL AND HUMAN, CULTURED	Hematology	864.2280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61685	Cancer/tumour-associated aneuploidy 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 evaluate a clinical specimen to diagnose, monitor or predict one or multiple acquired aneuploidies associated with cancer, such as aneuploidies of chromosome 3, 7, and 17 (associated with bladder cancer) or chromosome 8 and 12 [associated with B-cell chronic lymphocytic leukaemia (CLL) and myeloid disorders such as chronic myeloid leukaemia (CML) and acute myeloid leukaemia (AML)], in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999027046	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K953591	000
K962873	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – -20 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store ProbeChek Control Slides in a sealed container with desiccant to protect from humidity