Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016090200

FEI Number

3016090200

Entity Name

BONRAYBIO USA CORPORATION

City/State/Country

Diamond Bar, CA, US

Establishment Address

1300 VALLEY VISTA DR STE 207, Diamond Bar, CA 91765, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

BONRAYBIO USA CORPORATION (Owner Number: 10061873)

Owner / Operator Contact Address

1300 VALLEY VISTA DR STE 207, Diamond Bar, CA 91765, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242830

PMA Number

N/A

All Registered Proprietary Names

LensHooke Semen Test Cassette CS0;LensHooke Semen Test Cassette CS1 LensHooke X1 PRO Semen Quality Analyzer; LensHooke X1 PRO SE Semen Quality Analyzer LensHooke Cleaning Wipe CW0 LensHooke Cleaning Wipe CW1 LensHooke Prestained Morphology Slide CR0 LensHooke Semen Test Slide CS3 LensHooke R10 Plus Sperm DNA fragmentation Rapid Test Kit (SCD assay) LensHooke R11 Plus Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay) LensHooke X12 PRO Semen Analysis System; LensHooke CS3 10?m Semen Test Slide LensHooke CA1 Sperm Separation Device LensHooke CA0 Sperm Separation Device LensHooke X QC Beads (For Semen) LensHooke X QC Reticle (For Semen) LensHooke X QC Video (For Semen) LensHooke X QC Slide (For Semen) LensHooke Sperm DNA Fragmentation Test Kit (SCD Assay) LensHooke Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) LensHooke X1 Semen Quality Analyzer LensHooke Semen Test Cassette LensHooke X1 PRO Semen Quality Analyzer LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer; LensHooke CS1 Semen Test Cassette LensHooke Cleaning Wipe CW0; LensHooke Cleaning Wipe CW1; LensHooke Cleaning Wipe Holder CWA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2021-01-11
GHO	Hemocytometer	Hematology	Class 1	864.6160	2023-03-28
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2025-06-16
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2022-11-16
NRF	Material, Quality Control, Semen Analysis	Hematology	Class 2	864.8625	2020-03-12
IAF	Wright'S Stain	Hematology	Class 1	864.1850	2020-10-28
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2020-09-22
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2020-09-22
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2025-06-16

Official Correspondent

Cheng-Teng Hsu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BONRAYBIO USA CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

Similar Registrations

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1221433	HAMILTON THORNE, Inc.	Beverly, MA, US
3003646592	MEDICAL ELECTRONIC SYSTEMS LTD.	CAESAREA IND. PARK Haifa, IL
3015550658	MOTILITYCOUNT APS	Valby Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016090200. Last updated year: 2026. Please use registration number 3016090200 when referencing this establishment in official correspondence.