FDA.reportPublic FDA data

Panther Fusion®

Primary DI
15420045510470
Brand
Panther Fusion®
Company
Hologic, Inc.
Model
INTERNAL CONTROL-X, 960T, IVD
Catalog number
PRD-04476
Device description
Panther Fusion® Internal Control-X.
Published
2019-07-30
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
NJRNucleic acid amplification assay system, group b streptococcus, direct specimen test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen TestMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045510470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551047015420045510470

GMDN Terms#

Term, Definition table
TermDefinition
Exogenous DNA/RNA internal control IVD, kitA collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332940008161GeneXpert®CEPHEIDNJR2024-02-16
06974849369243Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369250Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369267Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369274Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369281Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPJiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
07332940007652Xpert®CEPHEIDNJR2022-07-29
07332940007669Xpert®CEPHEIDNJR2022-07-29
07332940007683GeneXpert®CEPHEIDNJR2022-05-03
07332940007690GeneXpert®CEPHEIDNJR2022-05-03
00840733102363Revogene GBS LBMERIDIAN BIOSCIENCE, INC.NJR2020-07-15
00628055344117Revogene® GBS LBMeridian Bioscience Canada IncNJR2019-10-21
15420045510890Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510463Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510906Panther Fusion®Hologic, Inc.NJR2019-07-30
10814278020045NeuMoDxTM GBS Test StripNeumodx Molecular, Inc.NJR2019-04-03
30014613336440SolanaDIAGNOSTIC HYBRIDS, INC.NJR2019-03-21
00840733102110Alethia™ Group B Streptococcus External Control KitMERIDIAN BIOSCIENCE, INC.NJR2019-01-08
00840733102196Alethia™ Group B StreptococcusMERIDIAN BIOSCIENCE, INC.NJR2019-01-08
20816101025644Simplexa™ GBS DirectDIASORIN MOLECULAR LLCNJR2018-11-20
20816101025651Simplexa™ GBS Positive Control PackDIASORIN MOLECULAR LLCNJR2018-11-20
30014613312024AmpliVueQUIDEL CORPORATIONNJR2018-08-30
07332940004521SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004538SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004545SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004569SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004583SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004606SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004767SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004880SmartCycler Dx SystemCEPHEIDNJR2018-07-03