FDA.reportPublic FDA data

PRODESSE

Primary DI
15420045506367
Brand
PRODESSE
Company
Hologic, Inc.
Model
PRO HMPV+ KIT, 100 REACTIONS
Catalog number
303671
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
OEMHuman metapneumovirus (hmpv) rna assay system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEMHuman Metapneumovirus (Hmpv) Rna Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132200000PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.2013-08-14OEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045506367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550636715420045506367

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
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
00850346007023CoolSeal™ GeneratorCSL-200-50CSL-200-502020-10-13
15420045515796EnvisionEnvision System Software LicenseCMP-019182026-10-09
15420045515802EnvisionEnvision Tomosynthesis LicenseCMP-029192026-10-09
15420045515864EnvisionEnvision Tomo Synthesized 2D LicenseCMP-019212026-10-09
15420045515871EnvisionEnvision 3DQorum LicenseCMP-019222026-10-09
15420045515895EnvisionEnvision SmartCurve Paddle LicenseCMP-019242026-10-09
15420045517462EnvisionENV-SYS-STDENV-SYS-STD2026-10-09
15420045517479EnvisionENV-SYS-STD-NSENV-SYS-STD-NS2026-10-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOEM2024-05-03
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOEM2023-04-06
00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OEM2020-01-10
00840487101612Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOEM2019-12-05
00840487101667Respiratory Pathogens Flex (RP Flex) Extraction TrayLUMINEX CORPORATIONOEM2019-12-05
00840487101711Respiratory Pathogens Flex (RP Flex) Amplification TrayLUMINEX CORPORATIONOEM2019-12-05
04053228033905QIAstat-Dx® Respiratory PanelQIAGEN GmbHOEM2019-05-24
10811877010521ID NOW RSVAlere Scarborough, Inc.OEM2018-10-29
10811877010538ID NOW RSV Control Swab KitAlere Scarborough, Inc.OEM2018-10-29
00857167005016ePlex SystemGENMARK DIAGNOSTICS, INC.OEM2018-01-03
00857167005023ePlex SystemGENMARK DIAGNOSTICS, INC.OEM2018-01-03
00857167005030ePlex SystemGENMARK DIAGNOSTICS, INC.OEM2017-12-29
15420045509290Panther Fusion®Hologic, Inc.OEM2017-12-15
15420045509320Panther Fusion®Hologic, Inc.OEM2017-12-15
15420045509214Panther Fusion®Hologic, Inc.OEM2017-11-08
15420045509221Panther Fusion®Hologic, Inc.OEM2017-11-08
15420045509252Panther Fusion®Hologic, Inc.OEM2017-11-08
15420045509269Panther Fusion®Hologic, Inc.OEM2017-11-08
15420045509276Panther Fusion®Hologic, Inc.OEM2017-11-08
00815381020154FilmArray® Respiratory Panel 2 (RP2)BIOFIRE DIAGNOSTICS, LLCOEM2017-07-18
00815381020161FilmArray® Respiratory Panel 2 (RP2)BIOFIRE DIAGNOSTICS, LLCOEM2017-07-18
00815381020147FilmArray® Respiratory Panel (RP) EZBIOFIRE DIAGNOSTICS, LLCOEM2016-12-06
10811877010118Alere i RSVAlere Scarborough, Inc.OEM2016-10-28
10811877010132Alere i RSV Control Swab KitAlere Scarborough, Inc.OEM2016-10-28
00857573006164Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeNANOSPHERE, INC.OEM2016-09-23
00857573006263Respiratory Pathogens Flex (RP Flex) Extraction TrayNANOSPHERE, INC.OEM2016-09-23
00857573006324Respiratory Pathogens Flex (RP Flex) Amplification TrayNANOSPHERE, INC.OEM2016-09-23
00815381020062FilmArray® Respiratory Panel (RP)BIOFIRE DIAGNOSTICS, LLCOEM2016-09-23
00815381020079FilmArray® Respiratory Panel (RP)BIOFIRE DIAGNOSTICS, LLCOEM2016-09-23
30014613311034LyraDIAGNOSTIC HYBRIDS, INC.OEM2016-09-15