Who else makes this device?

Name: TDGenet
Brand: TDGenet

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

TDGenet

Patient-centric software for genetics laboratories - Tailor-made software for cytogenetics and molecular genetics laboratories, and for coordinating all clinical genetics activities.

Registry build 21.09.26

7manufacturers in China registered for this device type

1catalogue number

4recalls on this code

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 TDGenet
Listed by	Technidata, France
FDA product code	JQP
Device type	Calculator/Data Processing Module, For Clinical Use
Device class	Class 1
Regulation	21 CFR 862.2100
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2023-02-15

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for TDGenet
Catalogue number	Size	Status
TDGenet		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

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2023-03-27	Class II	Software design	In a specific use case, when printing labels for slides, some labels may display wrong information	1 unit
2014-02-17	Class III	Software design	If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument.	85 units total (1 unit in US)	2014-03-31
2013-06-20	Class III	Software design	A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other symbol) in Microsoft Word reports when using electronic transmissions of results by of HPRIM (including HPRIM Medeci	1 site	2013-07-29
2010-07-29	Class II	Software design	Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request.	10	2013-12-05

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.