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Data / Medical devices / United States / Nano-Ditech Corporation

Nano-Ditech Corporation: FDA-registered device maker in Cranbury, NJ, United States, 8 510(k) clearances

Nano-Ditech Corporation is registered with the FDA (registration 3005174594) in Cranbury, NJ, United States. It lists 31 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 15, 2026. 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 Nano-Ditech Corporation
FDA registration number
3005174594
Address
259 Prospect Plains Rd Bldg K, Cranbury, NJ, United States, 08512
Owner or operator
NANO-DITECH CORPORATION (9071128)
Roles
Manufacturer, Manufacturer for export, Repackager or relabeler
First device listed
February 2, 2006
Registered through
2026
Brand names listed
CorDx Tyfast RSV Rapid Test, Fluoro-Check TM AMI 3 IN 1 Test, Fluoro-Check TM AMI cTnI Test, Fluoro-Check TM CRP Test, Fluoro-Check TM NT-proBNP Test, Fluoro-Check TM Vitamin D Test, Fluoro-Check TM iFOB, Fluoro-CheckTM ?-hCG and more

Devices it lists

DeviceProduct codeClassRoleSource
Antigen, Cf (Including Cf Controls), Respiratory Syncytial VirusGQG1Manufactureraccessdata.fda.gov
Antigen, Inflammatory Response Marker, SepsisNTM2Manufacturer for exportaccessdata.fda.gov
Block, HeatingJRG1Repackager or relabeleraccessdata.fda.gov
Chromatographic Separation, Cpk IsoenzymesJHT2Manufactureraccessdata.fda.gov
Covid-19 Multi-Analyte Antigen DeviceQMNNManufacturer for exportaccessdata.fda.gov
Covid-19 Test Home Collection Kit DevicesQLWNManufacturer for exportaccessdata.fda.gov
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) ClinicaJQT1Manufactureraccessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus AntigensPSZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Manufacturer for exportaccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Manufacturer for exportaccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Manufacturer for exportaccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Manufacturer for exportaccessdata.fda.gov
Enzyme Immunoassay, Nicotine And Nicotine MetabolitesMKU1Manufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUManufactureraccessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlDAP2Manufacturer for exportaccessdata.fda.gov
Fluorometer, For Clinical UseKHO1Manufactureraccessdata.fda.gov
High Pressure Liquid Chromatography, Tricyclic Antidepressant DrugsLFI2Manufacturer for exportaccessdata.fda.gov
Immunoassay Method, Troponin SubunitMMI2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Kit, Direct Antigen, Positive ControlMJZ1Manufactureraccessdata.fda.gov
Multi-Analyte Respiratory Virus Antigen Detection TestSCA2Manufactureraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Manufactureraccessdata.fda.gov
Reagent, Occult BloodKHE2Manufacturer for exportaccessdata.fda.gov
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient SettingsQVF2Manufactureraccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Manufacturer for exportaccessdata.fda.gov
System, Test, Vitamin DMRG2Manufacturer for exportaccessdata.fda.gov
Test, Natriuretic PeptideNBC2Manufacturer for exportaccessdata.fda.gov
Thin Layer Chromatography, MethamphetamineDJC2Manufactureraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Manufacturer for exportaccessdata.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 15, 2026K252283Nano-Check Influenza A+B TestPSZSubstantially EquivalentNano-Ditech Corporationaccessdata.fda.gov
June 17, 2025K243561Nano-Check Influenza+COVID-19 Dual TestSCASubstantially EquivalentNano-Ditech Corporationaccessdata.fda.gov
July 30, 2024K240280Nano-Check™ RSV TestGQGSubstantially EquivalentNano-Ditech Corporationaccessdata.fda.gov
January 23, 2024K231187Nano-Check™ COVID-19 Antigen TestQVFSubstantially EquivalentNano-Ditech Corporationaccessdata.fda.gov
October 20, 2010K102441NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBINMMISubstantially EquivalentNano-Ditech Corporationaccessdata.fda.gov
October 20, 2010K102131NANO-CHECK AMI CTNI CARDIAC MARKER TESTMMISubstantially EquivalentNano-Ditech Corporationaccessdata.fda.gov
March 2, 2006K050975NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBINMMISubstantially EquivalentNano-Ditech Co.accessdata.fda.gov
May 15, 2005K050594NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINELDJSubstantially EquivalentNano-Ditech Co.accessdata.fda.gov

Compare with other makers

Updated January 15, 2026. 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.