LensHooke X QC Reticle (For Semen)
LensHooke X QC Reticle is a reusable quality-control component for Bonraybio’s X1 PRO and X3 PRO semen analyzers. The manufacturer identifies the reticle as model QXA, with a polymer top…
LensHooke X QC Reticle is a reusable quality-control component for Bonraybio’s X1 PRO and X3 PRO semen analyzers. The manufacturer identifies the reticle as model QXA, with a polymer top cover and aluminum base. It provides three listed concentration levels for checking analyzer operation.
The three levels are negative control at 0 M/mL, Level 1 at 25±3 M/mL and Level 2 at 50±3 M/mL. X QC is a reticle component, while the X1 PRO or X3 PRO performs the semen analysis.
Listed Item
04719874740887 LensHooke X QC Reticle (For Semen)-L0 04719874740894 LensHooke X QC Reticle (For Semen)-L1 04719874740900 LensHooke X QC Reticle (For Semen)-L2 For BR USA CORP.
Construction and Range
The model’s top cover is polycarbonate and its base is aluminum. The manufacturer lists the same 75 × 28.6 × 7.65 mm dimensions and supported analyzer models for the QXA reticle.
The manufacturer specifies an operating and storage range of 15 to 38°C, at relative humidity below 70%.
Who Else Makes It
All of them in Jilin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
Record
| Listed by | Bonraybio Co., Ltd., Taiwan |
|---|---|
| FDA product code | NRF |
| Device type | Material, Quality Control, Semen Analysis |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X QC Reticle – 3 in1_BR USA CORP. | In distribution | |
| X QC Reticle – 3 in1_US | In distribution | |
| X QC Reticle – L1_US | In distribution | |
| X QC Reticle – L2_BR USA CORP. | In distribution | |
| X QC Reticle – L0_BR USA CORP. | In distribution | |
| X QC Reticle – L2_US | In distribution | |
| X QC Reticle – L0_US | In distribution | |
| X QC Reticle – L1_BR USA CORP. | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fertility Solutions | Fertility Solutions, Inc. | 8 |
| LensHooke X QC Video (For Semen) | Bonraybio Co., Ltd. | 5 |
| LensHooke X QC Slide (For Semen) | Bonraybio Co., Ltd. | 5 |
| Sperm-Chex | Streck LLC | 1 |
| LensHooke X QC Beads (For Semen) | Bonraybio Co., Ltd. | 1 |
| Sperm-Chex Post VC | Streck LLC | 1 |
| QwikCheck Beads | M.E.S. Medical Electronic Systems Ltd. | 1 |
| QwikCheck Beads Proficiency and Training Kit | M.E.S. Medical Electronic Systems Ltd. | 1 |
| accu-beads® | Hamilton Thorne, Inc. | 1 |
| QwikCheck Beads Precision and Linearity kit | M.E.S. Medical Electronic Systems Ltd. | 1 |
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.