FDA Registration
Active
🇺🇸 United States
NANO-DITECH CORPORATION
Reg #: 3005174594
·
FEI: 3005174594
·
Expires 2026
Products
30
Proprietary Names
35
Establishment Types
3
Classifications
30
Registration Details
- Registration Name
- NANO-DITECH CORPORATION
- Registration Number
- 3005174594
- FEI Number
- 3005174594
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 259 Prospect Plains Rd Bldg K
- City
- Cranbury
- State
- NJ
- ZIP
- 08512
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243561
Owner / Operator
- Firm Name
- NANO-DITECH CORPORATION
- Operator Number
- 9071128
- Address
- 259 Prospect Plains Rd, Bldg K
- City
- Cranbury
- State
- NJ
- Postal Code
- 08512
- Country
- US
- Correspondent
- James B Chang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | Class 2 | Microbiology | No | 2025-06-25 |
| Block, Heating | JRG | Class 1 | Clinical Chemistry | No | 2020-02-20 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2006-02-02 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2006-02-02 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2006-02-02 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2006-02-02 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2006-02-02 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2021-07-08 |
| Enzyme Immunoassay, Nicotine And Nicotine Metabolites | MKU | Class 1 | Clinical Toxicology | No | 2009-04-08 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2014-04-25 |
| Chromatographic Separation, Cpk Isoenzymes | JHT | Class 2 | Clinical Chemistry | No | 2006-03-29 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2006-03-29 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2006-03-29 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2024-08-06 |
| Covid-19 Multi-Analyte Antigen Device | QMN | Class N | Unknown | No | 2023-06-20 |
| Antigen, Inflammatory Response Marker, Sepsis | NTM | Class 2 | Microbiology | No | 2014-04-25 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2017-11-09 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2014-04-25 |
| Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | QVF | Class 2 | Microbiology | No | 2024-02-01 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2014-05-20 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2014-05-20 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2014-05-20 |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | Class 2 | Hematology | No | 2014-05-20 |
| Covid-19 Test Home Collection Kit Devices | QLW | Class N | Unknown | No | 2023-06-20 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2014-05-20 |
| High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs | LFI | Class 2 | Clinical Toxicology | No | 2014-05-20 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2016-03-28 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2008-10-14 |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | Class 2 | Microbiology | No | 2026-01-22 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2024-04-03 |
Proprietary Names
Nano-Check Influenza+COVID-19 Dual Test
Fluoro-CheckTM Heating Block
Nano-Check TM DAT 4M Test
Nano-Check TM OPI Test
Nano-Check TM DAT 5M Test
Fluoro-Check TM iFOB
Nano-Check TM Nicotine
Nano-Check TM NT-proBNP Test
Fluoro-Check TM NT-proBNP Test
Nano-Check TM AMI 4 IN 1 Test
Nano-Check TM AMI 3 IN 1 Cardiac Marker Test (cTnI, CK-MB, and Myoglobin)
Nano-Check RSV Test
Nano-CheckTM PCT plus
Nano-CheckTM PCT Test
Fluoro-CheckTM PCT Test
Fluoro-CheckTM ?-hCG
Fluoro-Check TM AMI cTnI Test
Fluoro-Check TM AMI 3 IN 1 Test
Nano-Check TM CRP Test
Nano-Check TM hsCRP Test
Fluoro-Check TM CRP Test
Nano-Check TM CRP plus Test
Nano-Check COVID-19 Antigen Test
Nano-Check TM DAT 10M Test
Nano-Check TM AMI 2 IN 1 Cardiac Marker (cTnI and Myoglobin)
Nano-CheckTM D-Dimer Test
Fluoro-CheckTM D-Dimer Test
Nano-Check TM COVID-19 Antigen At-Home Test
Fluoro-CheckerTM TRF Reader
Nano-Checker TM 710N Reader
Nano-Checker TM 710 Reader
Nano-Checker TM 710V Reader
Nano-Check Influenza A+B Test
Nano-Check TM AMI cTnI Cardiac Marker Test
Fluoro-Check TM Vitamin D Test
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only