PathVysion 02J01-036

GUDID 00884999001763

PathVysion HER-2 DNA Probe Kit

ABBOTT MOLECULAR INC.

C-erbB2/Her2/neu oncoprotein IVD, reagent

• Primary Device ID: 00884999001763
• NIH Device Record Key: 0d67b420-dcc4-4402-a9e3-11fd9e906e38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathVysion
• Version Model Number: 02J01-036
• Catalog Number: 02J01-036
• Company DUNS: 878263359
• Company Name: ABBOTT MOLECULAR INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999001763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980024

FDA Product Code

• MVD: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2014-11-20

On-Brand Devices [PathVysion]

• 00884999001855: ProbeChek PathVysion HER-2/neu Normal Control Slides
• 00884999001831: ProbeChek PathVysion HER-2/neu Cut-Off Control Slides
• 00884999001763: PathVysion HER-2 DNA Probe Kit
• 00884999001756: PathVysion HER-2 DNA Probe Kit
• 00884999001732: PathVysion HER-2 DNA Probe Kit