iXensor USA Inc

FDA Device Registration & Listing · San Juan Capistrano, CA, US · Registration 3017548799

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017548799
FEI Number
3017548799
Entity Name
iXensor USA Inc
City/State/Country
San Juan Capistrano, CA, US
Establishment Address
29122 Rancho Viejo Rd Ste 212, San Juan Capistrano, CA 92675, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
iXensor Co Ltd (Owner Number: 10048224)
Owner / Operator Contact Address
11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd.,, Neihu Dist,, Taipei, TW-TPE 114, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Eveline PixoTest CVSHealth PixoTest PixoTest

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2017-02-02
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2019-11-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

iXensor Co Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011061417 IXENSOR CO LTD Taipei, TW

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K920820 Helena Laboratories MODIFICATION COLUMNMATE 1992-08-17
K991850 Biosafe Laboratories, Inc. SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC 1999-11-26
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01
Z-0017-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0020-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

Similar Registrations

Registration Number Establishment Name Location
3013124221 MERIL DIAGNOSTICS PVT. LTD. Vapi Gujarat, IN
3015729142 Winx Health Inc Reading, PA, US
3027500452 TRUE DIAGNOSTICS, INC. Carlsbad, CA, US
3013885851 CENTUM ELECTRONICS LIMITED Bangalore Karnataka, IN
3008054239 CORE TECHNOLOGY CO., LTD. Changping District Beijing, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017548799. Last updated year: 2026. Please use registration number 3017548799 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.