FDA Registration
Active
🇨🇳 China
AVE SCIENCE & TECHNOLOGY CO., LTD
Reg #: 3031915160
·
FEI: 3031915160
·
Expires 2026
Products
22
Proprietary Names
29
Establishment Types
2
Classifications
22
Registration Details
- Registration Name
- AVE SCIENCE & TECHNOLOGY CO., LTD
- Registration Number
- 3031915160
- FEI Number
- 3031915160
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- AVE Medical Technology Park, No.26 Fuling Road Xueshi Community, Yuelu District
- City
- Changsha Hunan
- Country
- CN
Owner / Operator
- Firm Name
- AVE Science & Technology Co., Ltd
- Operator Number
- 10091279
- Address
- AVE Medical Technology Park, No.26 Fuling Road Xueshi Community, Yuelu, District, 410208 Changsha, Hunan Province, PEOPLE REPUBLIC OF CHINA
- City
- Changsha
- State
- Hunan
- Postal Code
- 410208
- Country
- CN
- Correspondent
- JIE LIU
US Agent
- Business Name
- PUREVISION AI, INC. (DBA PURE GLOBAL)
- Contact Name
- Bryan Wong
- Address
- 111 Town Square Pl Ste 1203
- City
- Jersey City
- State
- NJ
- ZIP
- 07310
- Country
- US
- [email protected]
- Phone
- 888 7681688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lactoferrin, Antigen, Antiserum, Control | DEG | Class 1 | Immunology | No | 2025-01-11 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2024-08-08 |
| Stains, Chemical Solution | LED | Class 1 | Hematology | No | 2025-01-11 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2024-08-08 |
| Antigens, Ha (Including Ha Control), Adenovirus 1-33 | GOB | Class 1 | Microbiology | No | 2024-08-08 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2025-01-11 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2024-08-08 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2025-01-11 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2025-01-11 |
| Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | OAM | Class 1 | Clinical Chemistry | No | 2024-08-08 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2025-01-11 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2025-01-11 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2024-08-08 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2025-01-11 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2025-01-11 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2025-01-11 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2025-01-11 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2024-08-08 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2024-09-04 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2024-09-04 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2024-08-08 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2025-01-11 |
Proprietary Names
Lactoferrin Rapid Test Kit (Colloidal Gold)
Luteinizing Hormone Rapid Test Kit (Colloidal Gold)
Gynecological Analysis Staining Solution
Gram Staining Solution
Wright's Giemsa Staining Solution
Urine Ketone Test Strips
Rotavirus Antigen Group A and Adenovirus Antigen Rapid Test Kit (Colloidal Gold)
Rotavirus Antigen Group A Rapid Test Kit (Colloidal Gold)
Adenovirus Antigen Rapid Test Kit (Colloidal Gold)
Urine Specific Gravity Test Strips
Urine Nitrite Test Strips
Diluent
Buffer
Cleanser
Female Lactic Acid Test Strips
Insulin-like Growth Factor Binding Protein 1 Rapid Test Kit (Colloidal Gold)
Helicobacter pylori Antigen Rapid Test Kit(Colloidal Gold)
Urine Microalbuminuria Test Strips
Urine Leukocytes Test Strips
Urine Urobilinogen Test Strips
Urine Ascorbic Acid Test Strips
Urine Bilirubin Test Strips
Fully Automatic Slide Stainer
Urine Analyzer
Female pH Test Strips
Urine pH Test Strips
Follicle-stimulating Hormone Rapid Test Kit(Colloidal Gold)
Urine Protein Test Strips
Slide Maker and Stainer
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device