Cervista 95-439

GUDID 15420045500167

Hologic, Inc.

Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 15420045500167
• NIH Device Record Key: 5ef3ba34-64f3-45df-9845-8c785331611b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervista
• Version Model Number: HPV 16 18
• Catalog Number: 95-439
• Company DUNS: 050579217
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045500167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080015

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: 2014-07-30

On-Brand Devices [Cervista]

• 15420045509627: Invader Ancillaries
• 15420045500167: HPV 16 18
• 15420045500150: HPV HR (768 Reactions)
• 15420045500143: HPV HR (96 Reactions)