FETAL FIBRONECTIN ENZYME IMMUNOASSAY 00480

GUDID 15420045505346

Hologic, Inc.

Fibronectin IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 15420045505346
• NIH Device Record Key: 6bcc7eac-d699-42b0-9174-553fc6d36645
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FETAL FIBRONECTIN ENZYME IMMUNOASSAY
• Version Model Number: 00480
• Catalog Number: 00480
• 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: 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045505346 [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: 2017-02-08

Devices Manufactured by Hologic, Inc.

• 15420045517639 - Selenia® Dimensions®: 2025-05-26 Hologic Selenia Dimensions Avia 3000 package for 2D screening mammography or optional 2D diagnostic.
• 15420045517646 - Selenia® Dimensions®: 2025-05-26 Hologic Selenia Dimensions 6000 package for 2D screening and diagnostic mammography. Upgradable to interventional or mobile.
• 15420045517585 - DIGITAL DIAGNOSTICS SYSTEM: 2025-04-11 Computer to operate the Genius™ Review Station.
• 15420045516991 - Aptima®: 2025-03-24 Aptima® SARS-CoV-2 Assay, 100 test, box 1 of 2 (2°C to 8°C box).
• 15420045517004 - Aptima®: 2025-03-24 Aptima® SARS-CoV-2 Assay, 100 test, box 2 of 2 (15°C to 30°C box).
• 15420045517035 - Aptima®: 2025-03-24 Aptima® SARS-CoV-2 Assay Controls Kit.
• 15420045517059 - Aptima®: 2024-12-27 Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test
• 15420045517066 - Aptima®: 2024-12-27 Aptima® BV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vitro nucleic acid amplification te