FDA UDI
In Commercial Distribution
🇺🇸 United States
LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)
DI: 14719874743571
·
Model: R10 Plus-01 Package-10 tests-US-HT
·
BONRAYBIO CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)
- Primary DI
- 14719874743571
- Version / Model
- R10 Plus-01 Package-10 tests-US-HT
- Catalog Number
- R10 Plus-01
- Company Name
- BONRAYBIO CO., LTD.
- Labeler DUNS
- 658872369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-06
- Public Version
- 1
- Public Version Date
- 2026-02-16
- Public Version Status
- New
- Public Device Record Key
- 24277347-c103-4f20-abe5-5ac16fc73b84
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| POV | Semen Analysis Device | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66248 | Spermatozoa chromatin dispersion (SCD) kit IVD | A collection of reagents and other associated materials intended to be used to visualize and determine the level of DNA fragmentation in spermatozoa, to aid in the assessment of male fertility using a cell-based optical technique (e.g., microscopy, flow cytometry). It typically consists of a denaturant, lysis solution, and/or microscope slides. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14719874743571 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242388 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 38 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- – 70 Percent (%) Relative Humidity