FDA Registration
Active
🇨🇳 China
SUZHOU TIANLONG BIOTECHNOLOGY CO., LTD.
Reg #: 3026312356
·
FEI: 3026312356
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- SUZHOU TIANLONG BIOTECHNOLOGY CO., LTD.
- Registration Number
- 3026312356
- FEI Number
- 3026312356
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building NE-33, Nanopolis, No.99 Jinjihu Avenue, Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone
- City
- Suzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Suzhou TianLong Biotechnology Co., Ltd.
- Operator Number
- 10086573
- Address
- Building NE-33, Nanopolis, No.99 Jinjihu Avenue, Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215123
- Country
- CN
- Correspondent
- Yangyang Wu
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 |
|---|---|---|---|---|---|
| Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | NJR | Class 1 | Microbiology | No | 2022-12-29 |
| Kit, Identification, Neisseria Gonorrhoeae | JSX | Class 1 | Microbiology | No | 2022-12-29 |
| Dna-Reagents, Legionella | LQH | Class 2 | Microbiology | No | 2022-12-29 |
| Antisera, All Types, Shigella Spp. | GNB | Class 2 | Microbiology | No | 2022-12-29 |
| Antigen, B. Pertussis | GOX | Class 1 | Microbiology | No | 2022-12-29 |
Proprietary Names
Group B Streptococcus (GBS) Nucleic Acid Detection Kit (Fluorescence PCR Method)
Neisseria Gonorrhoeae (NG) Nucleic Acid Detection Kit (Fluorescence PCR Method)
CT/NG/UU/UP Nucleic Acid Multiplex Detection Kit
Legionella Pneumophila Nucleic Acid Detection Kit (Fluorescence PCR Method)
Salmonella Enterica/Shigella Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)
Bacillus Pertussis Nucleic Acid Detection Kit (Fluorescence PCR Method)
Establishment Types
Manufacture Medical Device