FDA Registration
Active
🇺🇸 United States
LensHooke R10 Plus Sperm DNA fragmentation Rapid Test Kit (SCD assay)
Reg #: 3016090200
·
FEI: 3016090200
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BONRAYBIO USA CORPORATION
- Registration Number
- 3016090200
- FEI Number
- 3016090200
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1300 VALLEY VISTA DR STE 207
- City
- Diamond Bar
- State
- CA
- ZIP
- 91765
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242388
Owner / Operator
- Firm Name
- BONRAYBIO USA CORPORATION
- Operator Number
- 10061873
- Address
- 1300 VALLEY VISTA DR STE 207
- City
- Diamond Bar
- State
- CA
- Postal Code
- 91765
- Country
- US
- Correspondent
- Cheng-Teng Hsu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Semen Analysis Device | POV | Class 2 | Hematology | No | 2025-06-16 |
Proprietary Names
LensHooke R10 Plus Sperm DNA fragmentation Rapid Test Kit (SCD assay)
LensHooke X12 PRO Semen Analysis System; LensHooke CS3 10?m Semen Test Slide
LensHooke R11 Plus Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)
Establishment Types
Complaint File Establishment per 21 CFR 820.198