Who else makes this device?

Name: Sensititre Nephelometer
Brand: Sensititre Nephelometer

Clinical Chemistry › Laboratory InstrumentsNephelometer, For Clinical Use

Sensititre Nephelometer

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…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JQX
Manufacturer	City	Province	Registered as	Device types
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	4
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86

Record

Regulatory record for Sensititre Nephelometer
Listed by	Trek Diagnostic Systems, Ltd., United Kingdom
FDA product code	JQX
Device type	Nephelometer, For Clinical Use
Device class	Class 1
Regulation	21 CFR 862.2700
Establishment	Specification developer, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2022-12-14

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Sensititre Nephelometer
Catalogue number	Size	Status
V3011		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BD BBL™ CrystalSpec™ Calibration Tubes	Becton, Dickinson AND Company	1
BD Kiestra™ ID AST Calibrator Kit	Becton, Dickinson AND Company	1
Immage	Beckman Coulter, Inc.	1
BD PhoenixSpec™ AP Calibrator Kit	Becton, Dickinson AND Company	1
BD PhoenixSpec™ Calibrator 0.25 McFarland	Becton, Dickinson AND Company	1
BD PhoenixSpec™ Calibrator 0.50 McFarland	Becton, Dickinson AND Company	1
BD PhoenixSpec™ Calibrator 2.0 McFarland	Becton, Dickinson AND Company	1
BD Phoenix™ AP	Becton, Dickinson AND Company	1
BD PhoenixSpec™ Nephelometer	Becton, Dickinson AND Company	1
BD PhoenixSpec™ Calibrator Kit	Becton, Dickinson AND Company	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.