Cervista HTA System

GUDID 15420045501065

Hologic, Inc.

Nucleic acid sample preparation instrument IVD, semi-automated Nucleic acid sample preparation instrument IVD, semi-automated

• Primary Device ID: 15420045501065
• NIH Device Record Key: 88977837-f9fa-454b-9219-fa0a2e4e5411
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervista HTA System
• Version Model Number: Cervista HTA System Computer
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045501065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080014

FDA Product Code

• MAQ: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

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: 2014-09-02

On-Brand Devices [Cervista HTA System]

• 15420045501065: Cervista HTA System Computer
• 15420045500969: Cervista HTA System
• 15420045500952: Cervista HTA System