Roche Diagnostics (Suzhou) Ltd.
Registered establishment in Suzhou, Jiangsu, China. 3 device types.
Roche Diagnostics (Suzhou) Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Hexokinase, Glucose, General Purpose Reagent and 1 other device type. Its earliest product listing with the FDA dates from 2001.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3020917535 |
| FEI number | 3020917535 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 罗氏诊断产品（苏州）有限公司 |
|---|---|
| Unified social credit code | 913205943295977626 |
| Source | NMPA UDI database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No.259 Zhongyuan Road |
| Postal code | 215028 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| General Purpose Reagent | Class 1 | MPLC Cartridge Seal, Terminal Transferase, recomb. (24 000 U), dCTP,PCR Grade Di-Na slt, Ionify AxisSol cobas i 1x500ml, Ionify System Reagent VB2 (iSysR V2), Ionify iPTWB cobas i and 54 more | 2001 | 30 |
| Hexokinase, Glucose | Class 2 | GLUC HK Gen.3, 800Tests, cobas c, Int., GLUC HK Gen.3, 2200Tests, cobas c701, cobas INTEGRA GLUCOSE HK GEN 3, Glucose HK Gen. 3, Cobas Integra Glucose HK GEN. 3 Test System | 2008 | 2 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | Class 2 | Elecsys TSH, TSH Elecsys cobas e 200 V2, TSH Elecsys E2G 300 V2, TSH Elecsys E2G 100 V2 | 2019 | 2 |
Clearances
No clearance names Roche Diagnostics (Suzhou) Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K190773 | 2019-04-16 | JLW | Traditional | Roche Diagnostics Gmbh |
| K061048 | 2006-05-17 | CFR | Special | Roche Diagnostics Gmbh |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | Diagnostic systems, In vitro diagnostic reagents, Laboratory instruments, Blood testing equipment, Disease detection systems |
| Certifications | Medical device registration |
| Export markets | Global |
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.
The manufacturer named here can complete this record.