Panther Fusion® PRD-07401

GUDID 15420045515376

Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay Controls Kit.

Hologic, Inc.

Multiple respiratory virus nucleic acid IVD, control
Primary Device ID15420045515376
NIH Device Record Key216d08a4-30dd-4385-9b71-866f3a006a37
Commercial Distribution StatusIn Commercial Distribution
Brand NamePanther Fusion®
Version Model NumberKIT, SARS/FLU A/B/RSV CONTROLS, FUSION, IVD
Catalog NumberPRD-07401
Company DUNS050579217
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045515376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QOFMulti-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

On-Brand Devices [Panther Fusion®]

15420045516168Oil Reagent.
15420045515451Panther Fusion® Open Access® RNA/DNA Enzyme Cartridge, 96 tests.
15420045515376Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay Controls Kit.
15420045515352Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay, 96 tests.
15420045511415The RNA IC Probe ASR contains an oligonucleotide designed to detect the RNA target present in th
15420045511408The DNA IC Probe ASR contains an oligonucleotide designed to detect the DNA target present in th
15420045511392The RNA IC Primers ASR contains forward and reverse primers designed to amplify the RNA target p
15420045511088The DNA IC Primers ASR contains forward and reverse primers designed to amplify the DNA targets
15420045512139Hologic BKV Plasmid Control.
15420045511477BK virus (BKV) Probe ASR.
15420045511460BK virus (BKV) Primers ASR.
15420045510906Panther Fusion® GBS Controls Kit.
15420045510463Panther Fusion® Extraction Reagent-X.
15420045510920Specimen Transport Medium.
15420045512122Hologic EBV Plasmid Control.
15420045511590Group A Strep (GAS) Primers ASR.
15420045511576Group A Strep (GAS) Probe ASR.
15420045511552Hologic GAS Plasmid Control.
15420045511453Epstein-Barr virus (EBV) Probe ASR.
15420045511446Epstein-Barr virus (EBV) Primers ASR.
15420045511071Panther Fusion® Open Access® Diluent Additive.
15420045510944Blood Transport Medium.
15420045510937Urine Transport Medium.
15420045512146Hologic VZV Plasmid Control.
15420045512115Hologic CMV Plasmid Control.
15420045511491Varicella zoster virus (VZV) Probe ASR.
15420045511484Varicella zoster virus (VZV) Primers ASR.
15420045511439Cytomegalovirus (CMV) Probe ASR.
15420045511422Cytomegalovirus (CMV) Primers ASR.
15420045510890The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing re
15420045510470Panther Fusion® Internal Control-X.

Trademark Results [Panther Fusion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PANTHER FUSION
PANTHER FUSION
86575813 5233077 Live/Registered
Gen-Probe Incorporated
2015-03-25

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