FDA.reportPublic FDA data

Sensititre

Primary DI
M578GPID2
Brand
Sensititre
Company
TREK DIAGNOSTIC SYSTEMS LIMITED
Model
GPID
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LQMGram Negative Identification Panel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQMGram Negative Identification PanelMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M578GPID2PrimaryHIBCC0
M578GPID0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kitA collection of reagents and other associated materials intended to be used to determine the identification and antimicrobial susceptibility profile of gram positive bacteria species isolated from a clinical specimen by culture.

Contacts#

Phone, Email table
PhoneEmail
8006427029info.Trek.US@thermofisher.com

Regulatory Flags#

DUNS number
298203498
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05032384574230CMC1NJNFCMC1NJNF2026-05-06
05032384569588STP8FSTP8F2026-03-19
05032384474370SensititreGPN3F2025-04-11
05032384490813SensititreGPALL3F2025-04-11
05032384500406SensititreFDANDPF2025-04-11
05032384522941SensititreGN7F2025-04-11
05032384574384SensititreHPB22025-04-11
05032384576050SensititreARUP1MDF2025-04-11
05032384571499SensititreGPN3F2025-04-11
05032384571482SensititreGPALL3F2025-04-11
05032384571574SensititreFDANDPF2025-04-11
05032384571758SensititreGN7F2025-04-11
05032384580132SensititreHPB22025-04-11
05032384580613SensititreARUP1MDF2025-04-11
05032384551811SensititreSTP7F 2024-07-24
05032384557615SensititreMDRGN3F 2024-07-24
05032384561742SensititreGNUR5F2024-07-24
05032384571413SensititreYO3IVD2024-07-25
05032384571451SensititreYO2IVD2024-07-25
05032384571536SensititreESB1F2024-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590798987MicroScanBeckman Coulter, Inc.LQM2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.LQM2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.LQM2025-12-08
00848838074325PLATE DRY CLI GRAM+ ID AUTOREMEL, INC.LQM2023-06-20
05032384127917MICROBACT REAGENT SET DOXOID LIMITEDLQM2022-12-07
15099590655402MicroScanBeckman Coulter, Inc.LQM2022-12-05
15099590657239MicroScanBeckman Coulter, Inc.LQM2022-12-05
15099590657321MicroScanBeckman Coulter, Inc.LQM2022-12-05
15099590657604MicroScanBeckman Coulter, Inc.LQM2022-12-05
05032384127955MICROBACT GNB 24E TRAY (40 ID'S)OXOID LIMITEDLQM2022-12-04
05032384127962MICROBACT GNB 12A STRIP (60 ID'S)OXOID LIMITEDLQM2022-12-04
05032384127979MICROBACT GNB 12B STRIP (60 ID'S)OXOID LIMITEDLQM2022-12-04
15099590655181MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655198MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655204MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655211MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655228MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655235MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655242MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655259MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655495MicroscanBeckman Coulter, Inc.LQM2022-11-15
15099590655686MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655709MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655808MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655822MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655846MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655853MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655860MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655884MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590765361MicroScanBeckman Coulter, Inc.LQM2022-08-01