FDA Registration
Active
🇯🇵 Japan
Nagase Diagnostics Co., Ltd, Diagnostics Division, Ohito Diagnostics Plant
Reg #: 8043889
·
FEI: 3003206796
·
Expires 2026
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- Nagase Diagnostics Co., Ltd, Diagnostics Division, Ohito Diagnostics Plant
- Registration Number
- 8043889
- FEI Number
- 3003206796
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 632-1 Mifuku
- City
- Izunokuni-shi Shizuoka
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K170147
Owner / Operator
- Firm Name
- Nagase Diagnostics Co., Ltd.
- Operator Number
- 10059378
- Address
- 12-15, Nihonbashi-Kobunacho
- City
- Chuo-ku
- State
- Tokyo
- Postal Code
- 103-0024
- Country
- JP
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2018-12-28 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-12-28 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2018-12-28 |
Establishment Types
Manufacture Medical Device