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LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- LensHooke Sperm DNA fragmentation rapid test kit (SCD assay) FDA UDI
- Generic Name
- Spermatozoa chromatin dispersion (SCD) kit IVD FDA UDI
- Model / Reference
- R10 Plus Package-10 tests-US-BR FDA UDI
Identifiers
- Catalog Number
- R10 Plus FDA UDI
- Primary DI / UDI-DI
- 14719874742796 FDA UDI
- FDA Product Code
- IAF FDA UDI
- GMDN Term
- Spermatozoa chromatin dispersion (SCD) kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spermatozoa chromatin dispersion (SCD) kit IVD
LensHooke Sperm DNA fragmentation rapid test kit (SCD assay) by Bonraybio Co., Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Spermatozoa chromatin dispersion (SCD) kit IVD.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bonraybio Co., Ltd.
Sources (2)
- FDA UDI 0d473dcc-2739-498a-a34f-8fdef95545e5 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026