FDA.reportPublic FDA data

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

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