FDA.reportPublic FDA data

PRODESSE

Primary DI
15420045506329
Brand
PRODESSE
Company
Hologic, Inc.
Model
PRODESSE PROFLU+ ASSAY
Catalog number
303111
Published
2016-04-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OCCRespiratory virus panel nucleic acid assay system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132129000PRODESSE PROFLU+ ASSAYGen-Probe Prodesse, Inc.2013-08-09OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045506329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550632915420045506329

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 one or 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2024-07-26
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOCC2024-05-03
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2023-05-09
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOCC2023-04-06
B540FAB1100CW0Accula Flu A / B TestMESA BIOTECH, INC.OCC2022-10-17
B540FAB1100CWC0Accula Flu A / B Control KitMESA BIOTECH, INC.OCC2022-10-17
10811877011221ID NOW Influenza A & B 2 Control Swab KitAlere Scarborough, Inc.OCC2022-08-05
20816101026962Simplexa™ Flu A/B & RSV Direct Gen IIDIASORIN MOLECULAR LLCOCC2020-08-29
B540D20010Accula Programming CassetteMESA BIOTECH, INC.OCC2020-06-08
B540D20000Accula Dock MESA BIOTECH, INC.OCC2020-04-13
00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OCC2020-01-10
00840487101612Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOCC2019-12-05
00840487101667Respiratory Pathogens Flex (RP Flex) Extraction TrayLUMINEX CORPORATIONOCC2019-12-05
00840487101711Respiratory Pathogens Flex (RP Flex) Amplification TrayLUMINEX CORPORATIONOCC2019-12-05
B54010290Silaris RSV Control KitMESA BIOTECH, INC.OCC2019-07-29
B54010350Sialris Influenza A&B Supplemental PackMESA BIOTECH, INC.OCC2019-07-29
B54010400Silaris RSV Supplemental PackMESA BIOTECH, INC.OCC2019-07-29
04053228033905QIAstat-Dx® Respiratory PanelQIAGEN GmbHOCC2019-05-24
30014613336068SolanaDIAGNOSTIC HYBRIDS, INC.OCC2018-11-16
10811877010422ID NOW Influenza A & B 2Alere Scarborough, Inc.OCC2018-10-29
10811877010439ID NOW Influenza A & B Control Swab KitAlere Scarborough, Inc.OCC2018-10-29
10811877010521ID NOW RSVAlere Scarborough, Inc.OCC2018-10-29
10811877010538ID NOW RSV Control Swab KitAlere Scarborough, Inc.OCC2018-10-29
15415219000635Idylla™ Respiratory (IFV-RSV) PanelBiocartis NVOCC2018-10-23
30014613336143SolanaDIAGNOSTIC HYBRIDS, INC.OCC2018-08-07
B54010240 Silaris Influenza A&B Control KitMESA BIOTECH, INC.OCC2018-03-15
B54010270Silaris Influenza A&B TestMESA BIOTECH, INC.OCC2018-03-15
B54010280SilarisTM Influenza A&B Starter PackMESA BIOTECH, INC.OCC2018-03-15
07332940000783Xpert FLU/RSV XCCEPHEIDOCC2018-01-29
07332940001070Xpert FluCEPHEIDOCC2018-01-29