Panther Fusion® PRD-04986

GUDID 15420045511439

Cytomegalovirus (CMV) Probe ASR.

Hologic, Inc.

Cytomegalovirus (CMV) nucleic acid IVD, reagent

• Primary Device ID: 15420045511439
• NIH Device Record Key: 27ecc9e7-46a4-4239-a325-d7d1630df987
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panther Fusion®
• Version Model Number: DNA CMV PROBE (ASR)
• Catalog Number: PRD-04986
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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 -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045511439 [Primary]

FDA Product Code

• MVU: Reagents, specific, analyte

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: 2024-06-18
• Device Publish Date: 2024-06-10

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.
• 15420045511071: Panther Fusion® Open Access® Diluent Additive.
• 15420045510944: Blood Transport Medium.
• 15420045510937: Urine Transport Medium.
• 15420045512146: Hologic VZV Plasmid Control.
• 15420045512115: Hologic CMV Plasmid Control.
• 15420045511491: Varicella zoster virus (VZV) Probe ASR.
• 15420045511484: Varicella zoster virus (VZV) Primers ASR.
• 15420045511439: Cytomegalovirus (CMV) Probe ASR.
• 15420045511422: Cytomegalovirus (CMV) Primers ASR.
• 15420045510890: The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing re
• 15420045510470: Panther Fusion® Internal Control-X.