Data / Medical devices / China / Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.: FDA-registered device maker in Nantong Jiangsu, China, 1 510(k) clearance
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. is registered with the FDA (registration 3016733849) in Nantong Jiangsu, China. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 13, 2023. 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.
- FDA registration number
- 3016733849
- Address
- No.888, Zhujiang Road, Juegang Street, Rudong County Life and Health Industrial Park of Rudong High-tech Zone, Nantong Jiangsu, China, 226499
- Owner or operator
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. (10084191)
- Roles
- Manufacturer
- First device listed
- January 24, 2022
- Registered through
- 2026
- Brand names listed
- Adenovirus Antigen Detection Kit (Immunochromatography), Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Immunochromatography), Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold), Easy Amp Real-time Fluorescence Isothermal Detection System, EudemonTM AIO800, Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR), Group A Streptococcus Antigen Detection Kit (Immunochromatography), Group B Streptococcus Antigen Detection Kit (Immunochromatography), Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigens, All Groups, Streptococcus Spp. | GTY | 1 | Manufacturer | accessdata.fda.gov |
| Antigens, Ha (Including Ha Control), Adenovirus 1-33 | GOB | 1 | Manufacturer | accessdata.fda.gov |
| Clinical Sample Concentrator | JJH | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Manufacturer | accessdata.fda.gov |
| Fluorometer, For Clinical Use | KHO | 1 | Manufacturer | accessdata.fda.gov |
| Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | OAM | 1 | Manufacturer | accessdata.fda.gov |
| Instrumentation For Clinical Multiplex Test Systems | NSU | 2 | Manufacturer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer | accessdata.fda.gov |
| Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | NJR | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, Clostridium Difficile Toxin | LLH | 1 | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 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 |
|---|---|---|---|---|---|---|
| October 13, 2023 | K230741 | Macro & Micro-Test HCG Pregnancy Test Midstream | LCX | Substantially Equivalent | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen, Non-Sterile
- All makers of Instrumentation For Clinical Multiplex Test Systems
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Clinical Sample Concentrator
- All makers of Antigens, Ha (Including Ha Control), Adenovirus 1-33
Updated October 13, 2023. 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.