Rapid fFN for the Tli IQ System

GUDID 15420045501171

Hologic, Inc.

Fibronectin IVD, kit, enzyme immunohistochemistry Fibronectin IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 15420045501171
• NIH Device Record Key: d38dc1d2-2bfa-4c94-a110-d19b90cc7b43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid fFN for the Tli IQ System
• Version Model Number: 01175
• Company DUNS: 024741117
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045501171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P920048

FDA Product Code

• LKV: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-30

On-Brand Devices [Rapid fFN for the Tli IQ System]

• 15420045501171: 01175
• 15420045501164: 1166