Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016764932

FEI Number

3016764932

Entity Name

ZHEJIANG GENE SCIENCE CO., LTD

City/State/Country

shaoxing Zhejiang, CN

Establishment Address

no. 2 workshop, pharmaceutical industrial park, no. 11 shengxing road, shangyu economic and technological dev, shaoxing Zhejiang 312300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang GENE SCIENCE Co., Ltd (Owner Number: 10071254)

Owner / Operator Contact Address

no. 2 workshop, pharmaceutical industrial park, no. 11 shengxing road, shangyu economic and technological dev, shaoxing, CN-ZJ 312300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tourniquet, Nonpneumatic Red Blood Cell Lysis Buffer Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography) Sample Preservation Solution Disposable breathing circuit Tissue Floating Bath TF-45 Tissue Floating Bath&Slide Dryer WBFT-60 Paraffin Dispensers (EMB-03) Paraffin Dispensers (EMB-01) Paraffin Dispensers (EMB-02) Automatic Sorting&Checking Machine S1600/S1600V Chaser SPS slides laser Printer GSSPS-S Automatic Sorting&Checking Machine S800V Specimen High-Speed Pneumatic Transport System Whistle-O Pasteur Pipette Automatic Sorting&Checking Machine S1800V Specimen High-Speed Pneumatic Transport System Whistle-M Chaser CPS Embedding Cassette laser printer: GSCPS280,GSCPS-6,GSCPS-1,GSCPS-S,GSCPS-4,GSCPS-E Transport Tube Specimen Container Saliva Collection Kit Urine Collection Kit Urine Cup Sample Dispensing System Magic-8000Plus Nucleic Acid (DNA) Extraction Kit Nucleic Acid (RNA) Extraction Kit Nucleic Acid Extraction Kit SMART-05 Nucleic Acid Extractor Full-Auto IHC Stainer (P17) Full-Auto Slide Stainer & Coverslipper (GSM230) Fully Automated Special Staining System Automated Liquid-Based Cytology Slide Preparation Machine GSTCT-50 Full-Auto IHC Stainer (P17 plus) Liquid-based Thin Layer Cytology Slide System GSTCT-40plus Full-Auto Slide Stainer & Coverslipper Automatic Frozen Section Staining and Coverslipping Machine (GSM210-1/GSM210-2) Liquid-based Thin Layer Cytology Slide System GSTCT-18 Acid-fast Bacillus Staining Kit nasopharyngeal airway Saliva Collector Saliva Collection Kit Specimen Container Urine Collection Kit Urine Cup Papanicolaou Stain Tourniquet, Pneumatic Micro Pipettes Pipette Tips STETHOSCOPE Clod Plate EML-01 Microtome Disposable Virus Sampling Swab Kit Vaginal Swab Kit Cervical Swab Kit Anti-CD3 Monoclonal Primary Antibody Anti-Cytokeratin Monoclonal Primary Antibody Anti-S100 Monoclonal Primary Antibody Anti-CD20 Monoclonal Primary Antibody Anti-Desmin Monoclonal Primary Antibody Anti-Estrogen Receptor (ER) Monoclonal Primary Antibody Anti-HER2/neu Monoclonal Primary Antibody Anti-CD68 Monoclonal Primary Antibody Anti-PSA Monoclonal Primary Antibody Anti-CD34 Monoclonal Primary Antibody Anti-P53 Monoclonal Primary Antibody Anti-Ki67 Monoclonal Primary Antibody Anti-Smooth Muscle Actin (SMA) Monoclonal Primary Antibody Anti-Vimentin Monoclonal Primary Antibody Anti-Progesterone Receptor (PR) Monoclonal Primary Antibody Cell Block Preparation Kit Smart Cell Block System (BK-TYPE01) Smart Cell Block System Hot Plate TB-45

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2023-01-11
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2023-08-10
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-04-21
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2024-04-10
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2025-06-30
IDY	Bath, Flotation, Tissue	Pathology	Class 1	864.3010	2024-11-01
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2022-06-23
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2022-08-16
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2020-06-17
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2022-02-07
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2022-02-09
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2022-09-15
ICL	Carbol Fuchsin	Hematology	Class 1	864.1850	2024-01-24
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2022-11-11
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2021-02-23
HZJ	Stain, Papanicolau	Hematology	Class 1	864.1850	2024-01-24
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2023-03-06
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2022-02-15
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2023-01-05
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2024-11-01
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2024-11-01
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2022-01-27
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2024-11-01
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2022-06-23
JRG	Block, Heating	Clinical Chemistry	Class 1	862.2050	2024-11-01

Official Correspondent

Zhang GENESCIENCE

US Agent Details

Jianwei Zheng Business: Precision Diagnostics INC Email: JZheng@pdiax.com Phone: (508) 3489888

Related Public Records

Same Entity

Zhejiang GENE SCIENCE Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016764932. Last updated year: 2026. Please use registration number 3016764932 when referencing this establishment in official correspondence.