Zhejiang Gene Science Co., Ltd.
Manufacturer and brand owner in Shaoxing, Zhejiang, China. 31 device types, 1 product catalogued, 1 clearance.
Zhejiang Gene Science Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Hematoxylin, Micro Pipette and 29 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
31device types registered with the FDA
1product
1510(k) clearance
Registration
| Registered name | ZHEJIANG GENE SCIENCE CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016764932 |
| FEI number | 3016764932 |
| DUNS | 415610563 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 浙江峻山生物科技有限公司 |
|---|---|
| Unified social credit code | 91330604MA2BDA930U |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Shaoxing |
|---|---|
| Province | Zhejiang |
| Address | no. 2 workshop, pharmaceutical industrial park, no. 11 shengxing road, shangyu economic and technological dev |
| Postal code | 312300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Agent, Clearing | Class 1 | Greener Dewaxing Agent | 2023 | 1 |
| Airway, Nasopharyngeal | Class 1 | nasopharyngeal airway | 2022 | 52 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Nasopharyngeal/Oropharyngeal, Specimen collection swab, Antiseptic Swab Sticks/Applicators, Cervical Specimen Collection Flocked Swab, Cervical Specimen Collection Swab, Vaginal Swab | 2020 | 100 |
| Bath, Flotation, Tissue | Class 1 | Tissue Floating Bath TF-45, Tissue Floating Bath&Slide Dryer WBFT-60 | 2024 | 6 |
| Block, Heating | Class 1 | Hot Plate TB-45 | 2024 | 6 |
| Calculator/Data Processing Module, For Clinical Use | Class 1 | Sample Dispensing System Magic-8000Plus | 2022 | 7 |
| Carbol Fuchsin | Class 1 | Acid-fast Bacillus Staining Kit | 2024 | 1 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Disposable breathing circuit | 2025 | 55 |
| Clinical Sample Concentrator | Class 1 | SMART-05 Nucleic Acid Extractor, Nucleic Acid (DNA) Extraction Kit, Nucleic Acid Extraction Kit, Nucleic Acid (RNA) Extraction Kit | 2022 | 27 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | Stool Collection Kit | 2022 | 51 |
| Container, Specimen, Non-Sterile | Class 1 | Saliva Collector, Saliva Collection Kit, Specimen Container, Urine Collection Kit, Urine Cup | 2021 | 115 |
| Container, Specimen, Sterile | Class 1 | Specimen Container, Saliva Collection Kit, Transport Tube, Urine Cup, Urine Collection Kit | 2020 | 79 |
| Coverslips, Microscope Slide | Class 1 | Pathology Slide Kit | 2025 | 32 |
| Culture Media, Non-Selective And Non-Differential | Class 1 | Disposable Virus Sampling Swab Kit, Vaginal Swab Kit, Cervical Swab Kit | 2022 | 18 |
| Cytocentrifuge | Class 1 | Smart Cell Block System (BK-TYPE01), Cell Block Preparation Kit, Smart Cell Block System | 2022 | 3 |
| Device, Accessory, Cooling Plate For Tissue Embedding Station | Class 1 | Clod Plate EML-01 | 2024 | 7 |
| Dispensers, Paraffin | Class 1 | Paraffin Dispensers (EMB-03), Paraffin Dispensers (EMB-02), Paraffin Dispensers (EMB-01) | 2022 | 7 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Pasteur Pipette, Chaser CPS Embedding Cassette laser printer: GSCPS280,GSCPS-6,GSCPS-1,GSCPS-S,GSCPS-4,GSCPS-E, Chaser SPS slides laser Printer GSSPS-S, Specimen High-Speed Pneumatic Transport System Whistle-O, Automatic Sorting&Checking Machine S800V, Automatic Sorting&Checking Machine S1600/S1600V and 2 more | 2022 | 72 |
| General Purpose Reagent | Class 1 | Blocking Reagent, High pH Antigen Retrieval Solution, Secondary Antibodies Kit, DAB (Diaminobenzidine) Reagent, Wash Buffer, PAP (Peroxidase-Antiperoxidase) Reagent and 2 more | 2024 | 30 |
| Hematoxylin | Class 1 | Hematoxylin-Eosin Staining Solution | 2023 | 3 |
| Immunohistochemistry Reagents And Kits | Class 1 | Anti-Cytokeratin Monoclonal Primary Antibody, Anti-Estrogen Receptor (ER) Monoclonal Primary Antibody, Anti-PSA Monoclonal Primary Antibody, Anti-Ki67 Monoclonal Primary Antibody, Anti-CD68 Monoclonal Primary Antibody, Anti-CD20 Monoclonal Primary Antibody and 9 more | 2024 | 7 |
| Micro Pipette | Class 1 | Micro Pipettes, Pipette Tips | 2022 | 29 |
| Microbial Nucleic Acid Storage And Stabilization Device | Class 2 | Sample Preservation Solution | 2024 | 3 |
| Microtome, Rotary | Class 1 | Microtome | 2024 | 6 |
| Products, Red-Cell Lysing Products | Class 1 | Red Blood Cell Lysis Buffer | 2023 | 3 |
| Reagent, Coronavirus Serological | Class N | Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography) | 2020 | 12 |
| Slide Stainer, Automated | Class 1 | Full-Auto IHC Stainer (P17), Full-Auto Slide Stainer & Coverslipper, Full-Auto Slide Stainer & Coverslipper (GSM230), Automated Liquid-Based Cytology Slide Preparation Machine GSTCT-50, Full-Auto IHC Stainer (P17 plus), Fully Automated Special Staining System and 3 more | 2022 | 14 |
| Stain, Papanicolau | Class 1 | Papanicolaou Stain | 2024 | 4 |
| Stethoscope, Manual | Class 1 | Stethoscope | 2023 | 64 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet, Nonpneumatic | 2023 | 124 |
| Tourniquet, Pneumatic | Class 1 | Tourniquet, Pneumatic | 2023 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Zhejiang Gene Science | QBD | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212878 | 2024-04-08 | QBD | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2017 |
|---|---|
| Main products | PD-L1/HER2 immunohistochemistry kits, Chemiluminescence diagnostic kits, FISH detection reagents, Clinical staining reagents, Monoclonal antibody research kits |
Nearby Manufacturers
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.
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