Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005174594

FEI Number

3005174594

Entity Name

NANO-DITECH CORPORATION

City/State/Country

Cranbury, NJ, US

Establishment Address

259 Prospect Plains Rd Bldg K, Cranbury, NJ 08512, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

NANO-DITECH CORPORATION (Owner Number: 9071128)

Owner / Operator Contact Address

259 Prospect Plains Rd, Bldg K, Cranbury, NJ 08512, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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-Check Influenza+COVID-19 Dual 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 DAT 10M 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 Nano-Check TM DAT 10M Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	Class 2	866.3987	2025-06-25
JRG	Block, Heating	Clinical Chemistry	Class 1	862.2050	2020-02-20
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2006-02-02
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2006-02-02
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2006-02-02
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2006-02-02
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2006-02-02
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2021-07-08
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites	Clinical Toxicology	Class 1	862.3220	2009-04-08
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2014-04-25
JHT	Chromatographic Separation, Cpk Isoenzymes	Clinical Chemistry	Class 2	862.1215	2006-03-29
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2006-03-29
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2006-03-29
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2024-08-06
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2023-06-20
NTM	Antigen, Inflammatory Response Marker, Sepsis	Microbiology	Class 2	866.3210	2014-04-25
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2017-11-09
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2017-07-27
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2014-04-25
QVF	Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	Microbiology	Class 2	866.3982	2024-02-01
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2014-05-20
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2014-05-20
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2014-05-20
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2010-12-29
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2010-12-29
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2014-05-20
QLW	Covid-19 Test Home Collection Kit Devices	Unknown	Class N	N/A	2023-06-20
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2014-05-20

Official Correspondent

James Chang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NANO-DITECH 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
K110182	Guangzhou Wondfo Biotech Co., Ltd.	CANNABINOIDS URINE TEST	2011-05-20
K121557	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST	2012-07-25
K920418	Instrumentation Laboratory CO	IL TEST CANNABINOID, 35282	1992-02-27
K924751	Solarcare Technologies Corp,Inc.	SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY	1992-12-11
K142044	Guangzhou Wondfo Biotech Co., Ltd.	CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE	2014-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2022	Beckman Coulter Inc.	2	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Z-0052-2021	Siemens Healthcare Diagnostics, Inc.	2	Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005174594. Last updated year: 2026. Please use registration number 3005174594 when referencing this establishment in official correspondence.