Panther Fusion® PRD-04477

GUDID 15420045510463

Panther Fusion® Extraction Reagent-X.

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

• Primary Device ID: 15420045510463
• NIH Device Record Key: bae9edb7-20cc-439d-ac21-3c9795c79d98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panther Fusion®
• Version Model Number: EXTRACTION REAGENT-X, 960T, IVD
• Catalog Number: PRD-04477
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

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
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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	15420045510463 [Primary]

FDA Product Code

• NJR: Nucleic acid amplification assay system, group b streptococcus, direct specimen test

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-30
• Device Publish Date: 2019-07-30

On-Brand Devices [Panther Fusion®]

• 15420045516168: Oil Reagent.
• 15420045515451: Panther Fusion® Open Access® RNA/DNA Enzyme Cartridge, 96 tests.
• 15420045515376: Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay Controls Kit.
• 15420045515352: Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay, 96 tests.
• 15420045511415: The RNA IC Probe ASR contains an oligonucleotide designed to detect the RNA target present in th
• 15420045511408: The DNA IC Probe ASR contains an oligonucleotide designed to detect the DNA target present in th
• 15420045511392: The RNA IC Primers ASR contains forward and reverse primers designed to amplify the RNA target p
• 15420045511088: The DNA IC Primers ASR contains forward and reverse primers designed to amplify the DNA targets
• 15420045512139: Hologic BKV Plasmid Control.
• 15420045511477: BK virus (BKV) Probe ASR.
• 15420045511460: BK virus (BKV) Primers ASR.
• 15420045510906: Panther Fusion® GBS Controls Kit.
• 15420045510463: Panther Fusion® Extraction Reagent-X.
• 15420045510920: Specimen Transport Medium.
• 15420045512122: Hologic EBV Plasmid Control.
• 15420045511590: Group A Strep (GAS) Primers ASR.
• 15420045511576: Group A Strep (GAS) Probe ASR.
• 15420045511552: Hologic GAS Plasmid Control.
• 15420045511453: Epstein-Barr virus (EBV) Probe ASR.
• 15420045511446: Epstein-Barr virus (EBV) Primers ASR.