← Back to catalogue
LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay) FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Model / Reference
- R11 Plus Package-10 tests-US-BR FDA UDI
Identifiers
- Catalog Number
- R11 Plus FDA UDI
- Primary DI / UDI-DI
- 14719874742901 FDA UDI
- FDA Product Code
- KQC FDA UDI
- GMDN Term
- Biological stain 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: Biological stain IVD
LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay) by Bonraybio Co., Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Biological stain IVD.
- Rowley Biochemical Congo Red, 0.1% Aqueous — Transene Company, Inc. · Class I
- REMEL — REMEL, INC. · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- Rowley Biochemical Crystal Violet, 2% Aqueous — Transene Company, Inc. · Class I
- Hematek® Stain Pak - Wright-Giemsa Stain — Siemens Healthcare Diagnostics · Class I
- BD BBL™ TB Fluorescent Stain Kit M — BECTON DICKINSON AND COMPANY · Class I
- REMEL — REMEL, INC. · Class I
- REMEL — REMEL, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bonraybio Co., Ltd.
Sources (2)
- FDA UDI 94db9649-525d-4207-9027-752546ab6b3d 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026