Dynamiker Biotechnology (Tianjin) Co., Ltd.
Registered establishment in Tianjin, China. 3 device types.
Dynamiker Biotechnology (Tianjin) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Antigen, Elisa, Cryptococcus, Antigen, Cf, Aspergillus Spp. and 1 other device type. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012452932 |
| FEI number | 3012452932 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 丹娜（天津）生物科技股份有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | No. 2 Building, Rongzhi Industry Park, No. 3667, Zhongbin Avenue, Sino-Singapore Eco-city, TEDA, Tianjin300467 |
| Postal code | 300467 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Antigen, Cf, Aspergillus Spp. | Class 1 | QuicIgG^TM Aspergillus IgG Ab Lateral Flow Assay, Dynamiker Aspergillus fumigatus IgG Assay | 2019 | 1 |
| Antigen, Elisa, Cryptococcus | Class 2 | Dynamiker Cryptococcal Antigen Lateral Flow Assay(LFA) | 2019 | 1 |
| Candida Species, Antibody Detection | Class 2 | Dynamiker Candida Mannan Assay, Dynamiker Candida albicans IgG Assay, Dynamiker Candida IgG Lateral Flow Assay(LFA) | 2019 | 1 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | Fungal detection kits, Drug resistance testing kits, Infectious disease test kits, Endotoxin testing kits, Veterinary diagnostic kits |
| Certifications | 80+ patents, 92 CE certificates, ISO 13485, AEO Advanced Enterprise, National key specialized innovative little giant enterprise |
| Export markets | 80+ countries across Asia, Europe, South America, North America |
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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