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.

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• 15420045517882 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517899 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517905 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
• 15420045517912 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
• 15420045517929 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
• 15420045517936 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b