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Data / Medical devices / United States / Alius Scientific,LLC

Alius Scientific,LLC: FDA-registered device maker in Carolina, PR, United States, 8 510(k) clearances

Alius Scientific,LLC is registered with the FDA (registration 3010324880) in Carolina, PR, United States. It lists 27 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 12, 2017. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Alius Scientific,LLC
FDA registration number
3010324880
Address
Calle 246 PB54 Country Club, Carolina, PR, United States, 00982
Owner or operator
Alius Scientific, LLC (10072559)
Roles
Complaint file establishment
First device listed
July 22, 2021
Registered through
2026
Brand names listed
ADAM rWBC Kit, DIRUI CS480, DIRUI H500 URINALYSIS SYSTEM, DIRUI ISE DILUENT, DIRUI ISE INTERNAL STANDARD, FREND FT4, FREND PSA, FREND TESTOSTERONE and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)JMA1Complaint file establishmentaccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Complaint file establishmentaccessdata.fda.gov
Automated Urinalysis SystemKQO1Complaint file establishmentaccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Complaint file establishmentaccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Complaint file establishmentaccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Complaint file establishmentaccessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical UseJJQ1Complaint file establishmentaccessdata.fda.gov
Counter, Differential CellGKZ2Complaint file establishmentaccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Complaint file establishmentaccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Complaint file establishmentaccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Complaint file establishmentaccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Complaint file establishmentaccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Complaint file establishmentaccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Complaint file establishmentaccessdata.fda.gov
Fluorometer, For Clinical UseKHO1Complaint file establishmentaccessdata.fda.gov
General Purpose ReagentPPM1Complaint file establishmentaccessdata.fda.gov
Hexokinase, GlucoseCFR2Complaint file establishmentaccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Complaint file establishmentaccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Complaint file establishmentaccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Complaint file establishmentaccessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate CancersLTJ2Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Free ThyroxineCEC2Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Complaint file establishmentaccessdata.fda.gov
Refractometer For Clinical UseJRE1Complaint file establishmentaccessdata.fda.gov
System, Test, Vitamin DMRG2Complaint file establishmentaccessdata.fda.gov
Test, Urine LeukocyteLJX1Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 12, 2017K162754FREND Vitamin D Test SystemMRGSubstantially EquivalentNanoentek USA, Inc.accessdata.fda.gov
October 14, 2016K153577FREND Testosterone Test SystemCDZSubstantially EquivalentNanoentek USA, Inc.accessdata.fda.gov
February 17, 2016K152422FREND™ Free T4 Test SystemCECSubstantially EquivalentNanoentek USA, Inc.accessdata.fda.gov
May 16, 2014K133519CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CARJJESubstantially EquivalentCarolina Liquid Chemistries Corp.accessdata.fda.gov
March 14, 2014K131928FREND TSH (REAGENT CARTRIDGE)JLWSubstantially EquivalentNanoentek USA, Inc.accessdata.fda.gov
May 29, 2013K124056FREND PSA PLUS (REAGENT CARTRIDGE)LTJSubstantially EquivalentNanoentek, Inc.accessdata.fda.gov
April 27, 2010K091472URITEST 50 AND URITEST 500 URINE ANALYZERKQOSubstantially EquivalentArj Medical, Inc.accessdata.fda.gov
August 26, 2004K040703URISTIK H SERIES REAGENT STRIPS FOR URINALYSISJIOSubstantially EquivalentDirui Industrial Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated January 12, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.