Suzhou Sniper Medical Technologies Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 4 device types, 1 clearance.
Suzhou Sniper Medical Technologies Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers General Purpose Reagent, Bcr/Abl1 Monitoring Test and 2 other device types. Its earliest product listing with the FDA dates from 2021.
4device types registered with the FDA
1510(k) clearance
Registration
| Registered name | SUZHOU SNIPER MEDICAL TECHNOLOGIES CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021269066 |
| FEI number | 3021269066 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Unit 301, Building A6, Suzhou BioBAY, No. 218 Xinghu Street, Suzhou Industrial Park |
| Postal code | 215000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bcr/Abl1 Monitoring Test | Class 2 | BCR-ABL1 (p210) %IS Kit (Digital PCR Method) | 2023 | 1 |
| Clinical Sample Concentrator | Class 1 | (48T), Whole blood Nucleic Acid Extraction Reagent, Nucleic Acid Extraction System | 2022 | 27 |
| Droplet Digital Pcr System | Class 2 | BCR-ABL1 (p210) %IS Kit (Digital PCR Method), All-in-one Digital PCR Device | 2021 | 1 |
| General Purpose Reagent | Class 1 | Digital PCR Reaction Premix, (II-D-FAM;II-D-ROX;II-D-CY5.5;II-R-FAM;II-R-ROX;II-R-CY5.5) | 2022 | 30 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K221869 | 2023-09-05 | OYX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2018 |
|---|---|
| Main products | Digital PCR system, DQ24 Series, DQ-Infinity, Thunderbolt 9, Celatlas Space |
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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