Nano Ditech Corp

FDA Filings

This page includes the latest FDA filings for Nano Ditech Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Nano Ditech Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Sehyun Jang

FDA Registration(s)

• Registration Number: 3005174594
• FEI Number: 3005174594
• Name: NANO-DITECH CORPORATION
• Owner & Operator: NANO-DITECH CORPORATION
• Contact Address: 259 Prospect Plains Rd Bldg K; Cranbury NJ 08512 US
• Official Correspondent:
  • Joo Young - Choi
  • x-609-4093300-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 259 Prospect Plains Rd Bldg K ; Cranbury, NJ 08512 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 10895160002844 NANO-DITECH CORPORATION	Nano-Check Influenza+COVID-19 Dual Test	2024-08-16
GUDID 00895160002854 NANO-DITECH CORPORATION	Nano-Check RSV Test	2024-08-16
GUDID 10895160002868 NANO-DITECH CORPORATION	Nano-Check TM COVID-19 Antigen Test MD-8147 2T	2024-04-09
GUDID 10895160002240 NANO-DITECH CORPORATION	Nano-Check™ OPI Test	2023-07-05
GUDID 00895160002472 NANO-DITECH CORPORATION	Nano-CheckTM Dengue NS1 MD8143	2023-06-29
GUDID 00895160002434 NANO-DITECH CORPORATION	Fluoro-CheckTM NT-proBNP TF3152	2023-06-29
GUDID 00895160002427 NANO-DITECH CORPORATION	Fluoro-CheckTM PCT TF3161	2023-06-29
GUDID 00895160002410 NANO-DITECH CORPORATION	Fluoro-CheckTM cTnI TF3151	2023-06-29
GUDID 00895160002366 NANO-DITECH CORPORATION	Nano-CheckTM Nicotine 500 AD6183	2023-06-29
GUDID 00895160002359 NANO-DITECH CORPORATION	Nano-CheckTM Nicotine AD6083	2023-06-29
GUDID 00895160002120 NANO-DITECH CORPORATION	Nano-CheckTM AMI 2 in 1 CD202P	2023-06-29
GUDID 10895160002783 NANO-DITECH CORPORATION	Nano-Check TM COVID-19 Antigen Test	2022-06-10
GUDID 00895160002458 NANO-DITECH CORPORATION	Nano-CheckTM 4 in 1 Test CD402P	2022-06-10
GUDID 00895160002441 NANO-DITECH CORPORATION	Nano-CheckTM PCT plus CD7156	2022-06-10
GUDID 00895160002113 NANO-DITECH CORPORATION	Nano-CheckTM AMI cTnI CD7140	2022-06-10
GUDID 00895160002076 NANO-DITECH CORPORATION	Nano-CheckTM AMI cTnI CD7141	2022-06-10
GUDID 00895160002069 NANO-DITECH CORPORATION	Nano-CheckTM NT-proBNP CD7154	2022-06-10
GUDID 00895160002052 NANO-DITECH CORPORATION	Nano-CheckTM hs-CRP CD7152	2022-06-10
GUDID 00895160002045 NANO-DITECH CORPORATION	Nano-CheckTM CRP CD7151	2022-06-10
GUDID 00895160002038 NANO-DITECH CORPORATION	Nano-CheckTM PCT CD7155	2022-06-10
GUDID 00895160002021 NANO-DITECH CORPORATION	Nano-CheckTM AMI CK-MB CD7142	2022-06-10
GUDID 10895160002707 NANO-DITECH CORPORATION	Fluoro-Check TM Strep A Test	2022-03-23
GUDID 10895160002691 NANO-DITECH CORPORATION	Nano-Check TM CRP plus Test	2022-03-23
GUDID 10895160002684 NANO-DITECH CORPORATION	Nano-Check TM Strep A Test	2022-03-23
GUDID 00895160002151 NANO-DITECH CORPORATION	Nano-CheckTM D-Dimer CD7153	2021-09-20
GUDID 00895160002489 NANO-DITECH CORPORATION	Nano-CheckTM Dengue IgM/IgG MD8144	2021-08-09
GUDID 00895160002557 NANO-DITECH CORPORATION	Nano-CheckTM DAT 10M AD102U	2021-05-24
GUDID 00895160002540 NANO-DITECH CORPORATION	Nano-CheckTM DAT 4M AD405U	2021-05-24
GUDID 00895160002533 NANO-DITECH CORPORATION	Nano-CheckTM DAT 5M AD508U	2021-05-24
GUDID 00895160002229 NANO-DITECH CORPORATION	Nano-CheckTM DAT 6M AD601U	2021-05-24
GUDID 00895160002144 NANO-DITECH CORPORATION	Nano-CheckTM DAT 10M AD101U	2021-05-24
GUDID 10895160002790 NANO-DITECH CORPORATION	Fluoro-Check TM COVID-19 Antigen Test	2020-12-03
GUDID 10895160002721 NANO-DITECH CORPORATION	Nano-Check TM COVID-19 IgG Antibody Test	2020-09-30
GUDID 10895160002677 NANO-DITECH CORPORATION	Fluoro-CheckTM CRP Test	2020-09-30
GUDID 10895160002660 NANO-DITECH CORPORATION	Nano-CheckTM COVID-19 IgG/IgM Antibody Test	2020-04-20
GUDID 00895160002618 NANO-DITECH CORPORATION	Fluoro-CheckTM iFOB TF8145	2020-04-06
GUDID 00895160002649 NANO-DITECH CORPORATION	Fluoroo-Check Heating Block HB101	2020-02-28
JRG NANO-DITECH CORPORATION	Fluoro-CheckTM Heating Block	2020-02-20
GUDID 00895160002465 NANO-DITECH CORPORATION	Nano-CheckTM Malaria MD8142	2019-10-07
GUDID 00895160002632 NANO-DITECH CORPORATION	Nano-CheckTM DAT 6M AD603U	2019-07-11
GUDID 00895160002625 NANO-DITECH CORPORATION	Nano-CheckTM DAT 6M AD602U	2019-07-11
GUDID 00895160002601 NANO-DITECH CORPORATION	Fluoro-CheckTM Vitamin D TF8148	2019-06-03
GUDID 00895160002526 NANO-DITECH CORPORATION	Fluoro-CheckTM Influenza A+B TF8147	2019-06-03
GUDID 00895160002502 NANO-DITECH CORPORATION	Fluoro-CheckTM D-Dimer TF3162	2019-06-03
GUDID 00895160002496 NANO-DITECH CORPORATION	Fluoro-CheckTM AMI 3 in 1 TF3154	2019-06-03
GUDID 00895160002519 NANO-DITECH CORPORATION	Fluoro-CheckTM beta-hCG TF8146	2019-05-27
GUDID 00895160002595 NANO-DITECH CORPORATION	Nano-CheckTM DAT 10M AD104U	2019-05-13
GUDID 00895160002571 NANO-DITECH CORPORATION	Nano-CheckTM DAT 10M AD103U	2019-04-23
GUDID 00895160002564 NANO-DITECH CORPORATION	Nano-CheckTM DAT 4M AD407U	2019-04-23
GUDID 00895160002403 NANO-DITECH CORPORATION	Fluoro-CheckerTM TRF Reader TF101	2019-04-08
GUDID 00895160002014 NANO-DITECH CORPORATION	Nano-CheckerTM 710 Reader NDT710	2019-04-08
JHI NANO-DITECH CORPORATION	Fluoro-CheckTM ?-hCG	2017-11-09
MMI NANO-DITECH CORPORATION	Fluoro-CheckTM AMI cTnI	2017-07-27
KHO NANO-DITECH CORPORATION	Fluoro-CheckerTM TRF Reader	2016-03-28
LFI NANO-DITECH CORPORATION	Nano-Check TM DAT5B Test	2014-05-20
JXM NANO-DITECH CORPORATION	Nano-Check TM DAT5B Test	2014-05-20
JXM NANO-DITECH CORPORATION	Nano-Check DAT8M Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN)	2014-05-20
JXM NANO-DITECH CORPORATION	Nano-Check DAT6B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET)	2014-05-20
JXM NANO-DITECH CORPORATION	Nano-Check DAT10B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN, BAR, PCP)	2014-05-20
DKZ NANO-DITECH CORPORATION	Nano-Check TM DAT5B Test	2014-05-20
DKZ NANO-DITECH CORPORATION	Nano-Check DAT8M Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN)	2014-05-20
DKZ NANO-DITECH CORPORATION	Nano-Check DAT6B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET)	2014-05-20
DKZ NANO-DITECH CORPORATION	Nano-Check DAT3B Multi-line Drug of Abuse Test (THC, OPI, AMP)	2014-05-20
DKZ NANO-DITECH CORPORATION	Nano-Check DAT10B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN, BAR, PCP)	2014-05-20
DJR NANO-DITECH CORPORATION	Nano-Check TM DAT5B Test	2014-05-20
DJR NANO-DITECH CORPORATION	Nano-Check DAT8M Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN)	2014-05-20
DJR NANO-DITECH CORPORATION	Nano-Check DAT10B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN, BAR, PCP)	2014-05-20
DIS NANO-DITECH CORPORATION	Nano-Check TM DAT5B Test	2014-05-20
DIS NANO-DITECH CORPORATION	Nano-Check DAT10B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN, BAR, PCP)	2014-05-20
DAP NANO-DITECH CORPORATION	Nano-CheckTM D-Dimer Test	2014-05-20
DAP NANO-DITECH CORPORATION	Fluoro-CheckTM D-Dimer Test	2014-05-20
NTM NANO-DITECH CORPORATION	Nano-CheckTM PCT plus	2014-04-25
NTM NANO-DITECH CORPORATION	Nano-CheckTM PCT Test	2014-04-25
NTM NANO-DITECH CORPORATION	Fluoro-CheckTM PCT Test	2014-04-25
NBC NANO-DITECH CORPORATION	Nano-CheckTM Nt-proBNP Test	2014-04-25
NBC NANO-DITECH CORPORATION	Fluoro-CheckTM NT-proBNP Test	2014-04-25
DCN NANO-DITECH CORPORATION	Nano-CheckTM hsCRP Test	2014-04-25
DCN NANO-DITECH CORPORATION	Nano-CheckTM CRP Test	2014-04-25
DCN NANO-DITECH CORPORATION	Fluoro-CheckTM CRP Test	2014-04-25
PMN K102441 | MMI NANO-DITECH CORPORATION	Nano-Check AMI 2 in1, cTnI/Myoglobin	2010-12-29
PMN K102441 | MMI NANO-DITECH CORPORATION	In vitro Nano-CheckTM AMI 2 in 1 Cardiac Marker, cTnI and Myoglobin	2010-12-29
PMN K102441 | DDR NANO-DITECH CORPORATION	Nano-Check AMI 2 in1, cTnI/Myoglobin	2010-12-29
PMN K102441 | DDR NANO-DITECH CORPORATION	In vitro Nano-CheckTM AMI 2 in 1 Cardiac Marker, cTnI and Myoglobin	2010-12-29
PMN K102131 | MMI NANO-DITECH CORPORATION	Nano-Check AMI cTnI	2010-12-29
PMN K102131 | MMI NANO-DITECH CORPORATION	In vitro Nano-CheckTM AMI cTnI Cardiac Marker Test	2010-12-29
PMN K102131 | MMI NANO-DITECH CORPORATION	Fluoro-CheckTM AMI cTnI Test	2010-12-29
PMN K102441 NANO-DITECH CORPORATION	NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN	2010-10-20
PMN K102131 NANO-DITECH CORPORATION	NANO-CHECK AMI CTNI CARDIAC MARKER TEST	2010-10-20
MKU NANO-DITECH CORPORATION	Nano-CheckTM Nicotine	2009-04-08
JQT NANO-DITECH CORPORATION	Nano-Checker 710N	2008-10-14
JQT NANO-DITECH CORPORATION	Nano-Checker 710	2008-10-14
PMN K050975 | MMI NANO-DITECH CORPORATION	VARIOUS NAMES	2006-03-29
PMN K050975 | MMI NANO-DITECH CORPORATION	Nano-CheckTM AMI 3 in 1 Cardiac Marker Test cTnI, CK-MB and Myoglobin	2006-03-29
PMN K050975 | MMI NANO-DITECH CORPORATION	NANO-CHECK AMI 3 IN 1 CARDIOMARKER	2006-03-29
PMN K050975 | MMI NANO-DITECH CORPORATION	MES	2006-03-29
PMN K050975 | MMI NANO-DITECH CORPORATION	Fluoro-CheckTM AMI 3 in 1 Test	2006-03-29
PMN K050975 | JHT NANO-DITECH CORPORATION	VARIOUS NAMES	2006-03-29
PMN K050975 | JHT NANO-DITECH CORPORATION	Nano-CheckTM AMI 3 in 1 Cardiac Marker Test cTnI, CK-MB and Myoglobin	2006-03-29
PMN K050975 | JHT NANO-DITECH CORPORATION	NANO-CHECK AMI 3 IN 1 CARDIOMARKER	2006-03-29
PMN K050975 | JHT NANO-DITECH CORPORATION	MES	2006-03-29
PMN K050975 | JHT NANO-DITECH CORPORATION	Fluoro-CheckTM AMI 3 in 1 Test	2006-03-29
PMN K050975 | DDR NANO-DITECH CORPORATION	VARIOUS NAMES	2006-03-29
PMN K050975 | DDR NANO-DITECH CORPORATION	Nano-CheckTM AMI 3 in 1 Cardiac Marker Test cTnI, CK-MB and Myoglobin	2006-03-29
PMN K050975 | DDR NANO-DITECH CORPORATION	NANO-CHECK AMI 3 IN 1 CARDIOMARKER	2006-03-29
PMN K050975 | DDR NANO-DITECH CORPORATION	MES	2006-03-29
PMN K050975 | DDR NANO-DITECH CORPORATION	Fluoro-CheckTM AMI 3 in 1 Test	2006-03-29
PMN K050594 | LDJ NANO-DITECH CORPORATION	S AND MODELS	2006-02-02
PMN K050594 | LDJ NANO-DITECH CORPORATION	Nano-Check DAT8M Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN)	2006-02-02
PMN K050594 | LDJ NANO-DITECH CORPORATION	Nano-Check DAT6B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET)	2006-02-02
PMN K050594 | LDJ NANO-DITECH CORPORATION	Nano-Check DAT3B Multi-line Drug of Abuse Test (THC, OPI, AMP)	2006-02-02
PMN K050594 | LDJ NANO-DITECH CORPORATION	Nano-Check DAT10B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN, BAR, PCP)	2006-02-02
PMN K050594 | LDJ NANO-DITECH CORPORATION	NANO-CHECK DAT 5 MULTI SCREENING TE	2006-02-02
PMN K050594 | LDJ NANO-DITECH CORPORATION	NANO-CHECK DAT 5 MULTI DRUG SCREENI	2006-02-02
PMN K050594 | LDJ NANO-DITECH CORPORATION	MODELS	2006-02-02
PMN K050594 | LCM NANO-DITECH CORPORATION	S AND MODELS	2006-02-02
PMN K050594 | LCM NANO-DITECH CORPORATION	Nano-Check DAT8M Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN)	2006-02-02
PMN K050594 | LCM NANO-DITECH CORPORATION	Nano-Check DAT6B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET)	2006-02-02
PMN K050594 | LCM NANO-DITECH CORPORATION	Nano-Check DAT3B Multi-line Drug of Abuse Test (THC, OPI, AMP)	2006-02-02
PMN K050594 | LCM NANO-DITECH CORPORATION	Nano-Check DAT10B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN, BAR, PCP)	2006-02-02
PMN K050594 | LCM NANO-DITECH CORPORATION	NANO-CHECK DAT 5 MULTI SCREENING TE	2006-02-02
PMN K050594 | LCM NANO-DITECH CORPORATION	NANO-CHECK DAT 5 MULTI DRUG SCREENI	2006-02-02
PMN K050594 | LCM NANO-DITECH CORPORATION	MODELS	2006-02-02
PMN K050594 | DJG NANO-DITECH CORPORATION	S AND MODELS	2006-02-02
PMN K050594 | DJG NANO-DITECH CORPORATION	Nano-Check DAT8M Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN)	2006-02-02
PMN K050594 | DJG NANO-DITECH CORPORATION	Nano-Check DAT6B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET)	2006-02-02
PMN K050594 | DJG NANO-DITECH CORPORATION	Nano-Check DAT3B Multi-line Drug of Abuse Test (THC, OPI, AMP)	2006-02-02
PMN K050594 | DJG NANO-DITECH CORPORATION	Nano-Check DAT10B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN, BAR, PCP)	2006-02-02
PMN K050594 | DJG NANO-DITECH CORPORATION	NANO-CHECK DAT 5 MULTI SCREENING TE	2006-02-02
PMN K050594 | DJG NANO-DITECH CORPORATION	NANO-CHECK DAT 5 MULTI DRUG SCREENI	2006-02-02
PMN K050594 | DJG NANO-DITECH CORPORATION	MODELS	2006-02-02
PMN K050594 | DJC NANO-DITECH CORPORATION	S AND MODELS	2006-02-02
PMN K050594 | DJC NANO-DITECH CORPORATION	Nano-Check DAT8M Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN)	2006-02-02
PMN K050594 | DJC NANO-DITECH CORPORATION	Nano-Check DAT6B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET)	2006-02-02
PMN K050594 | DJC NANO-DITECH CORPORATION	Nano-Check DAT3B Multi-line Drug of Abuse Test (THC, OPI, AMP)	2006-02-02
PMN K050594 | DJC NANO-DITECH CORPORATION	Nano-Check DAT10B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN, BAR, PCP)	2006-02-02
PMN K050594 | DJC NANO-DITECH CORPORATION	NANO-CHECK DAT 5 MULTI SCREENING TE	2006-02-02
PMN K050594 | DJC NANO-DITECH CORPORATION	NANO-CHECK DAT 5 MULTI DRUG SCREENI	2006-02-02
PMN K050594 | DJC NANO-DITECH CORPORATION	MODELS	2006-02-02
PMN K050594 | DIO NANO-DITECH CORPORATION	S AND MODELS	2006-02-02
PMN K050594 | DIO NANO-DITECH CORPORATION	Nano-Check DAT8M Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN)	2006-02-02
PMN K050594 | DIO NANO-DITECH CORPORATION	Nano-Check DAT6B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET)	2006-02-02
PMN K050594 | DIO NANO-DITECH CORPORATION	Nano-Check DAT3B Multi-line Drug of Abuse Test (THC, OPI, AMP)	2006-02-02
PMN K050594 | DIO NANO-DITECH CORPORATION	Nano-Check DAT10B Multi-line Drug of Abuse Test (THC, OPI, AMP, COC, BZO, MET, MDMA, MDN, BAR, PCP)	2006-02-02
PMN K050594 | DIO NANO-DITECH CORPORATION	NANO-CHECK DAT 5 MULTI SCREENING TE	2006-02-02
PMN K050594 | DIO NANO-DITECH CORPORATION	NANO-CHECK DAT 5 MULTI DRUG SCREENI	2006-02-02
PMN K050594 | DIO NANO-DITECH CORPORATION	MODELS	2006-02-02

Related Finance Registrations

NCAGE Code	3EL18	NANO-DITECH CORPORATION
CAGE Code	3EL18	NANO-DITECH CORPORATION
DUNS	126544316	NANO-DITECH CORPORATION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202004234004	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	ALUMINIUM POUCH	2 PKG
2020040818451	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	ALUMINIUM POUCH	2 PKG
2020030525191	Pusan,South Korea -> Long Beach, California	CASSETTE	8 PKG
2019112124547	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	ALUMINIUM POUCH	1 PKG
2019081027528	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	CASSETTE	8 PKG
2019062222400	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	ALUMINIUM POUCH	3 PKG
2019041226510	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	DUAL CASSETTE 7616 99 9090	8 PKG
2019031524247	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	ALUMINUM POUCH 7616 99 9090	2 PKG