FDA Registration
Active
🇺🇸 United States
BONRAYBIO USA CORPORATION
Reg #: 3016090200
·
FEI: 3016090200
·
Expires 2026
Products
9
Proprietary Names
25
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- BONRAYBIO USA CORPORATION
- Registration Number
- 3016090200
- FEI Number
- 3016090200
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1300 VALLEY VISTA DR STE 207
- City
- Diamond Bar
- State
- CA
- ZIP
- 91765
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202089
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 | 2021-01-11 |
| Hemocytometer | GHO | Class 1 | Hematology | No | 2023-03-28 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2022-11-16 |
| Material, Quality Control, Semen Analysis | NRF | Class 2 | Hematology | No | 2020-03-12 |
| Wright'S Stain | IAF | Class 1 | Hematology | No | 2020-10-28 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2020-09-22 |
| Trypsin | IBG | Class 1 | Pathology | No | 2020-10-28 |
| Stains, Hematology | KQC | Class 1 | Hematology | No | 2021-12-17 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2020-09-22 |
Proprietary Names
LensHooke Semen Test Cassette CS0;LensHooke Semen Test Cassette CS1
LensHooke X1 PRO Semen Quality Analyzer; LensHooke X1 PRO SE Semen Quality Analyzer
LensHooke Cleaning Wipe CW0
LensHooke Cleaning Wipe CW1
LensHooke Prestained Morphology Slide CR0
LensHooke Semen Test Slide CS3
LensHooke R10 Plus Sperm DNA fragmentation Rapid Test Kit (SCD assay)
LensHooke R11 Plus Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)
LensHooke X12 PRO Semen Analysis System; LensHooke CS3 10?m Semen Test Slide
LensHooke CA1 Sperm Separation Device
LensHooke CA0 Sperm Separation Device
LensHooke X QC Beads (For Semen)
LensHooke X QC Reticle (For Semen)
LensHooke X QC Video (For Semen)
LensHooke X QC Slide (For Semen)
LensHooke Sperm DNA Fragmentation Test Kit (SCD Assay)
LensHooke Sperm DNA Fragmentation Rapid Test Kit (SCD Assay)
LensHooke X1 Semen Quality Analyzer
LensHooke Semen Test Cassette
LensHooke X1 PRO Semen Quality Analyzer
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer; LensHooke CS1 Semen Test Cassette
LensHooke Cleaning Wipe CW0; LensHooke Cleaning Wipe CW1; LensHooke Cleaning Wipe Holder CWA
LensHooke Liquefaction Enzyme
LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)
C-KUP Liquefaction Test Cup
Establishment Types
Complaint File Establishment per 21 CFR 820.198