Who else makes this device?

Name: Calculator/Data Processing Module, For Clinical Use
Brand: Calculator/Data Processing Module, For Clinical Use

Clinical Chemistry › Laboratory InstrumentsCalculator/Data Processing Module, For Clinical Use

Calculator/Data Processing Module, for Clinical Use

QBL Software License

Registry build 21.09.26

7manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (2), Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JQP
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Dongguan BAO Kang Dian ZI KE JI Limited	Dongguan	Guangdong	Contract manufacturer	24
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Zhejiang Gene Science Co., Ltd.	Shaoxing	Zhejiang	Manufacturer	31
Foshan Zike Technology Co., Ltd.	Foshan	Guangdong	Manufacturer	9
Tianjin Empecs Medical Device Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	8
Shanghai Bestcovered Limited	Shanghai	Shanghai	Manufacturer	2

Record

Regulatory record for Calculator/Data Processing Module, For Clinical Use
Listed by	Stryker GmbH, Switzerland
FDA product code	JQP
Device type	Calculator/Data Processing Module, For Clinical Use
Device class	Class 1
Regulation	21 CFR 862.2100
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2021-07-29

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only

Catalogue Numbers

Catalogue numbers for Calculator/Data Processing Module, For Clinical Use
Catalogue number	Size	Status
0794111090		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
SoftPathDx	SCC Soft Computer	69
SoftMolecular	SCC Soft Computer	67
SoftFlowCytometry	SCC Soft Computer	67
SoftBiochemistry	SCC Soft Computer	67
SoftCytogenetics	SCC Soft Computer	67
SoftMic	SCC Soft Computer	65
SoftLab	SCC Soft Computer	64
SoftTrack	SCC Soft Computer	61
SoftHLA	SCC Soft Computer	61
SoftGenomics	SCC Soft Computer	51
SoftGenePortal	SCC Soft Computer	48
SoftTotalQC	SCC Soft Computer	28

Showing 12 of 140. All products under Calculator/Data Processing Module, For Clinical Use

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.