Autobio Labtec Instruments Co., Ltd.
Registered establishment in Zhengzhou, Henan, China. 3 device types.
Autobio Labtec Instruments Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Real Time Nucleic Acid Amplification System, Analyzer, Chemistry, Micro, For Clinical Use and 1 other device type. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | AUTOBIO LABTEC INSTRUMENTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3025430789 |
| FEI number | 3025430789 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 安图实验仪器（郑州）有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Zhengzhou |
|---|---|
| Province | Henan |
| Address | No. 199, 15th Ave, National Eco & Tech Zone |
| Postal code | 450016 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Chemistry, Micro, For Clinical Use | Class 1 | Chemiluminescence Immunoassay Analyzer: AutoLumo A2000 Plus,AutoLumo A1000,AutoLumo A1820&A1860, AutoLumo A6200&A6600 | 2022 | 3 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Sample Cup, Reaction Vessel, M3000-PCR Tube, M3000-Tip Tray, M1600-PCR Tube, M3000-Tip Tray | 2022 | 72 |
| Real Time Nucleic Acid Amplification System | Class 2 | Automated Nucleic Acid Purification and Real Time PCR System | 2022 | 15 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Employees | 6000+ |
| Main products | Immunoassay analyzers, Microbiology systems, Molecular diagnostics, Coagulation analyzers, Biochemistry analyzers |
| Certifications | 326 IVDR CE certificates |
| Export markets | 20+ countries globally |
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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