FDA.reportPublic FDA data

SENSITITRE NEPHELOMETER

Primary DI
05032384474516
Brand
SENSITITRE NEPHELOMETER
Company
TREK DIAGNOSTIC SYSTEMS LIMITED
Model
V3011
Device description
The Sensititre™ Nephelometer is used for standardizing the inoculum density of a bacterial suspension. Light from an ultrabright light emitting diode (LED) is scattered by bacteria in suspension and detected by a photodiode. The quantity of scattered light is compared with a reference value obtained by calibrating the Nephelometer with a 0.5 McFarland turbidity standard.
Published
2022-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQXNephelometer, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQXNephelometer, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384474516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384474516050323844745165032384474516

GMDN Terms#

Term, Definition table
TermDefinition
Microorganism-density nephelometer IVDA mains electricity (AC-powered) laboratory instrument intended to be used to determine the density of microorganism suspensions by comparing the turbidity of a solution with that of McFarland standards using a photometric detection system.

Contacts#

Phone, Email table
PhoneEmail
+441256694238microbiology.techsupport.uk@thermofisher.com

Regulatory Flags#

DUNS number
298203498
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing 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
00382904440640BD Kiestra™ ID AST Calibrator KitBECTON, DICKINSON AND COMPANYJQX2024-08-29
15099590265403IMMAGEBeckman Coulter, Inc.JQX2020-08-24
00382902450153BD BBL™ CrystalSpec™ Calibration TubesBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904409104BD PhoenixSpec™ NephelometerBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904409111BD PhoenixSpec™ Calibrator KitBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904413552BD PhoenixSpec™ Calibrator 0.25 McFarlandBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904413569BD PhoenixSpec™ Calibrator 0.50 McFarlandBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904419516BD PhoenixSpec™ AP Calibrator KitBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904419530BD PhoenixSpec™ Calibrator 2.0 McFarlandBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904480103BD Phoenix™ APBECTON, DICKINSON AND COMPANYJQX2018-05-25