FDA Registration
Active
🇨🇳 China
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.
Reg #: 3016733849
·
FEI: 3016733849
·
Expires 2026
Products
11
Proprietary Names
18
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.
- Registration Number
- 3016733849
- FEI Number
- 3016733849
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.888, Zhujiang Road, Juegang Street, Rudong County, Life and Health Industrial Park of Rudong High-tech Zone
- City
- Nantong Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230741
Owner / Operator
- Firm Name
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- Operator Number
- 10084191
- Address
- No.888, Zhujiang Road, Juegang Street, Rudong County, Life and Health Industrial Park of Rudong High-tech Zone
- City
- Nantong
- State
- Jiangsu
- Postal Code
- 226499
- Country
- CN
- Correspondent
- Licheng Liu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antigens, Ha (Including Ha Control), Adenovirus 1-33 | GOB | Class 1 | Microbiology | No | 2022-08-30 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2022-08-25 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2023-03-30 |
| Reagents, Clostridium Difficile Toxin | LLH | Class 1 | Microbiology | No | 2022-08-30 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2023-11-09 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2022-01-24 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2022-01-24 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2022-08-30 |
| Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | NJR | Class 1 | Microbiology | No | 2022-08-17 |
| Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | OAM | Class 1 | Clinical Chemistry | No | 2022-08-30 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2022-01-24 |
Proprietary Names
Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)
Adenovirus Antigen Detection Kit (Immunochromatography)
Macro & Micro-Test Fluorescence Reader
Macro & Micro-Test Fluorescence Immunoassay Analyzer
Macro & Micro-Test LH Test
Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Immunochromatography)
Macro & Micro-Test HCG Preganancy Test Midstream
Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit
Macro & Micro-Test Viral DNA/RNA Kit
Macro & Micro-Test Sample Release Reagent
Macro & Micro-Test Automatic Nucleic Acid Extractor
Group A Streptococcus Antigen Detection Kit (Immunochromatography)
Group B Streptococcus Antigen Detection Kit (Immunochromatography)
Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)
Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus
Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochromatography)
Easy Amp Real-time Fluorescence Isothermal Detection System, EudemonTM AIO800
Establishment Types
Manufacture Medical Device