Panther Fusion PRD-06234

GUDID 15420045512924

Hologic, Inc.

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

• Primary Device ID: 15420045512924
• NIH Device Record Key: 91a67962-d159-4c95-8600-f3b4cfcac83a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panther Fusion
• Version Model Number: INTERNAL CONTROL-B, 960T, IVD
• Catalog Number: PRD-06234
• Company DUNS: 050579217
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• 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	15420045512924 [Primary]

FDA Product Code

• JJH: CLINICAL SAMPLE CONCENTRATOR

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-19
• Device Publish Date: 2021-03-11

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