Sensititre

Primary DI
M578GNID2
Brand
Sensititre
Company
TREK DIAGNOSTIC SYSTEMS LIMITED
Model
GNID
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
LQLGram Positive Identification Panel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQLGram Positive Identification PanelMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M578GNID2PrimaryHIBCC0
M578GNID0Unit 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
15099590799014MicroScanBeckman Coulter, Inc.LQL2025-12-08
05099590799017MicroScanBeckman Coulter, Inc.LQL2025-12-08
05032384128006Microbact Staph 12SOXOID LIMITEDLQL2024-10-28
05032384128013Microbact Staph Fast Blue ReagentOXOID LIMITEDLQL2024-10-28
00848838074363Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTOREMEL, INC.LQL2023-06-20
15099590657338MicroScanBeckman Coulter, Inc.LQL2022-12-05
15099590657581MicroScanBeckman Coulter, Inc.LQL2022-12-05
05032384127498MICROBACT LISTERIA 12L (20 ID'S)OXOID LIMITEDLQL2022-12-04
03573026529994VITEK® 2 GPBIOMERIEUX , INC.LQL2020-06-02
03573026131920VITEK® 2 GPBIOMERIEUX , INC.LQL2020-06-02
00382904480080BD Phoenix™ PIDBECTON, DICKINSON AND COMPANYLQL2018-05-25
30382902452400BD BBL™ Crystal™ GP Gram-Positive ID SystemBECTON, DICKINSON AND COMPANYLQL2018-05-25
30382902452509BD BBL™ Crystal™ Rapid Gram-Positive ID SystemBECTON, DICKINSON AND COMPANYLQL2018-05-25
30382904480081BD Phoenix™ PIDBECTON, DICKINSON AND COMPANYLQL2018-05-25
00382902450375BD BBL™ Crystal™ ID Systems Gram-Positive Manual CodebookBECTON, DICKINSON AND COMPANYLQL2018-05-25
00382902450412BD BBL™ Crystal™ ID Systems Rapid Gram-Positive Manual CodebookBECTON, DICKINSON AND COMPANYLQL2018-05-25
15099590704025MicroScanBeckman Coulter, Inc.LQL2018-05-11
15099590704032MicroScanBeckman Coulter, Inc.LQL2018-05-11
15099590657376MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657383MicroScan Beckman Coulter, Inc.LQL2016-09-02
15099590657406MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657475MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657499MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657529MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657543MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657567MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657574MicroScanBeckman Coulter, Inc.LQL2016-09-02