FDA.reportPublic FDA data

Panther Fusion®

Primary DI
15420045515352
Brand
Panther Fusion®
Company
Hologic, Inc.
Model
KIT, SARS/FLU A/B/RSV REAG CARTRDG, 96T, FUS, IVD
Catalog number
PRD-07400
Device description
Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay, 96 tests.
Published
2023-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QOFMulti-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222736000Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc.2023-05-16QOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045515352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551535215420045515352

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple viruses associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
050579217
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

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Primary DI, Brand, Company table
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00819704020487FINDER RVP BufferBaebies, Inc.QOF2026-05-01
00819704020630FINDER Flu A&B/SARS-CoV-2 Positive Control SwabBaebies, Inc.QOF2026-05-01
00819704020654FINDER Flu A&B/SARS-CoV-2 Negative Control SwabBaebies, Inc.QOF2026-05-01
05061098480025NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
05061098480032NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007329cobas® Respiratory flex Control KitRoche Molecular Systems, Inc.QOF2026-02-24
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20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCQOF2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCQOF2026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCQOF2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCQOF2026-01-14
04053228039402QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
14053228039409QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
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00884999049383Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
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00875197007305cobas liat SARS-CoV-2, Influenza A/B & RSV control kitRoche Molecular Systems, Inc.QOF2025-05-28
00810031720019Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
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