TLiIQ System 01202

GUDID 25420045500874

System that detects fFN in cervicovaginal secretions.

Hologic, Inc.

Fibronectin IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 25420045500874
• NIH Device Record Key: 6020f1f8-fc11-433d-8785-fce615105dc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLiIQ System
• Version Model Number: TLiIQ System
• Catalog Number: 01202
• Company DUNS: 018925968
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	25420045500874 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-15
• Device Publish Date: 2024-08-07

On-Brand Devices [TLiIQ System]

• 15420045500884: TLiIQ System Analyzer
• 15420045500877: TLiIQ System
• 25420045500874: System that detects fFN in cervicovaginal secretions.