PANTHER FUSION PRD-04335

GUDID 15420045509276

Hologic, Inc.

Nucleic acid technique (NAT) kit IVD Nucleic acid technique (NAT) kit IVD

• Primary Device ID: 15420045509276
• NIH Device Record Key: 1c7ec81e-39a7-4b55-a460-88c7f3fe75e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANTHER FUSION
• Version Model Number: OIL KIT, PANTHER FUSION, 1920T, IVD
• Catalog Number: PRD-04335
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045509276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171963

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: 2017-11-08

On-Brand Devices [PANTHER FUSION]

• 15420045509337: PARAFLU CTRLS KIT, PANTHER FUSION, IVD
• 15420045509320: AMR CTRLS, PANTHER FUSION, IVD
• 15420045509313: FLU A B RSV CTRLS, PANTHER FUSION, IVD
• 15420045509306: PARAFLU KIT, PANTHER FUSION, 96T, IVD
• 15420045509290: AMR KIT, PANTHER FUSION, 96T, IVD
• 15420045509283: FLU A B RSV, PANTHER FUSION, 96T, IVD
• 15420045509276: OIL KIT, PANTHER FUSION, 1920T, IVD
• 15420045509269: ELUTION KIT, PANTHER FUSION, 2400T, IVD
• 15420045509252: RECON-1 KIT, PANTHER FUSION, 1920T, IVD
• 15420045509238: SPECIMEN LYSIS TUBES, IVD
• 15420045509221: INTERNAL CONTROL-S, 960T, IVD
• 15420045509214: EXTRACTION REAGENT-S, 960T, IVD
• 15420045512924: INTERNAL CONTROL-B, 960T, IVD
• 15420045512917: EXTRACTION REAGENTS-B, 960T, IVD