LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (Sdfr Assay)
2 catalogue numbers from R11 Plus Package-10 tests-US-HT, listed by Bonraybio Co., Ltd., Taiwan, under Stains, Hematology. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Bonraybio Co., Ltd., Taiwan |
|---|---|
| FDA product code | KQC |
| Device type | Stains, Hematology |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-02-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R11 Plus Package-10 tests-US-HT | In distribution | |
| R11 Plus Package-10 tests-US-BR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Camco | Cambridge Diagnostic Products, Inc. | 7 |
| Coulter TruColor Giemsa Stain | Beckman Coulter, Inc. | 2 |
| Coulter TruColor Wright Stain | Beckman Coulter, Inc. | 2 |
| Coulter TruColor Wright- Giemsa Stain | Beckman Coulter, Inc. | 2 |
| Ral Diff-Quik Fixative Solution (1 x 2,5L) | R.A.L. Diagnostics | 1 |
| Ral Diff-Quik Solution I (1 x 2,5L) | R.A.L. Diagnostics | 1 |
| Coulter TruColor Wright Stain Buffer | Beckman Coulter, Inc. | 1 |
| Diff-Quik™ Fixative | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Coulter TruColor May Grünwald Stain | Beckman Coulter, Inc. | 1 |
| Diff-Quik™ Solution II | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Ral Diff-Quik EZ-Kit (3 x 100ml) | R.A.L. Diagnostics | 1 |
| STROMATOLYSER-4DS | Sysmex Corporation | 1 |
Showing 12 of 22. All products under Stains, Hematology
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.