Data / Medical devices / China / Zhejiang Gene Science Co., Ltd

Zhejiang Gene Science Co., Ltd: FDA-registered device maker in shaoxing Zhejiang, China, 1 510(k) clearance

Name: Zhejiang Gene Science Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zhejiang Gene Science Co., Ltd is registered with the FDA (registration 3016764932) in shaoxing Zhejiang, China. It lists 31 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 8, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Zhejiang Gene Science Co., Ltd

FDA registration number: 3016764932
Address: no. 2 workshop, pharmaceutical industrial park, no. 11 shengxing road, shangyu economic and technological dev, shaoxing Zhejiang, China, 312300
Owner or operator: Zhejiang GENE SCIENCE Co., Ltd (10071254)
Roles: Manufacturer
First device listed: April 21, 2020
Registered through: 2026
Brand names listed: Acid-fast Bacillus Staining Kit, Anti-CD20 Monoclonal Primary Antibody, Anti-CD3 Monoclonal Primary Antibody, Anti-CD34 Monoclonal Primary Antibody, Anti-CD68 Monoclonal Primary Antibody, Anti-Cytokeratin Monoclonal Primary Antibody, Anti-Desmin Monoclonal Primary Antibody, Anti-Estrogen Receptor (ER) Monoclonal Primary Antibody and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Clearing	KEM	1	Manufacturer	accessdata.fda.gov
Airway, Nasopharyngeal	BTQ	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Bath, Flotation, Tissue	IDY	1	Manufacturer	accessdata.fda.gov
Block, Heating	JRG	1	Manufacturer	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Manufacturer	accessdata.fda.gov
Carbol Fuchsin	ICL	1	Manufacturer	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Manufacturer	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Manufacturer	accessdata.fda.gov
Coverslips, Microscope Slide	KES	1	Manufacturer	accessdata.fda.gov
Culture Media, Non-Selective And Non-Differential	JSG	1	Manufacturer	accessdata.fda.gov
Cytocentrifuge	IFB	1	Manufacturer	accessdata.fda.gov
Device, Accessory, Cooling Plate For Tissue Embedding Station	MXT	1	Manufacturer	accessdata.fda.gov
Dispensers, Paraffin	IDW	1	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Hematoxylin	HYJ	1	Manufacturer	accessdata.fda.gov
Immunohistochemistry Reagents And Kits	NJT	1	Manufacturer	accessdata.fda.gov
Micro Pipette	JRC	1	Manufacturer	accessdata.fda.gov
Microbial Nucleic Acid Storage And Stabilization Device	QBD	2	Manufacturer	accessdata.fda.gov
Microtome, Rotary	IDO	1	Manufacturer	accessdata.fda.gov
Products, Red-Cell Lysing Products	GGK	1	Manufacturer	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Manufacturer	accessdata.fda.gov
Slide Stainer, Automated	KPA	1	Manufacturer	accessdata.fda.gov
Stain, Papanicolau	HZJ	1	Manufacturer	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Manufacturer	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 8, 2024	K212878	Sample preservation solution	QBD	Substantially Equivalent	Zhejiang Gene Science Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.