PRODESSE 303121

GUDID 15420045506336

Hologic, Inc.

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 15420045506336
• NIH Device Record Key: 70ae077f-aaa4-4c9c-a8a9-622c88e2bdd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRODESSE
• Version Model Number: PROFLU+ ASSAY KIT, 2,000 REACTIONS
• Catalog Number: 303121
• 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	15420045506336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132129

FDA Product Code

• OCC: Respiratory virus panel nucleic acid assay system

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: 2016-04-15

On-Brand Devices [PRODESSE]

• 15420045506398: PROPARAFLU+ KIT, 100 REACTIONS
• 15420045506381: PROADENO+ KIT, 100 REACTIONS
• 15420045506374: PROFAST+ KIT, 100 REACTIONS
• 15420045506367: PRO HMPV+ KIT, 100 REACTIONS
• 15420045506350: PROGASTRO SSCS ASSAY
• 15420045506343: PROFLU+ ASSAY KIT, 1,500 REACTIONS
• 15420045506336: PROFLU+ ASSAY KIT, 2,000 REACTIONS
• 15420045506329: PRODESSE PROFLU+ ASSAY