nano-ditech.com
nanoditech.comNano-Check? RSV Test
Nano-Ditech Corporation
NANO-DITECH CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005174594 | 3005174594 | NANO-DITECH CORPORATION | 1 | N | 2026-01-01 | 259 Prospect Plains Rd Bldg K Cranbury NJ US 08512 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00895160002427 | Fluoro-CheckTM PCT - Fluorescence In Vitro diagnostic test kit for the detection of Procalcitonin in human whole blood, serum or plasma | 609-409-3300 | info@nanoditech.com |
| 00895160002847 | Nano-Check Influenza+COVID-19 Dual Test - The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The Nano-Check™ Influenza+COVID-19 Dual Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved. | 609-409-3300 | info@nanoditech.com |
| 00895160002878 | Nano-Check™ Influenza A+B Test - The Nano-Check™ Influenza A+B Test is a lateral flow immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B nucleoprotein antigens directly from anterior nasal swab (ANS) samples from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections. The test is not intended for the detection of influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.Performance characteristics for influenza A and B were established during the 2022-2025 influenza seasons when influenza A/H1N1pdm09, influenza A/H3N2, and influenza B/Victoria lineage were the predominant influenza viruses in circulation. When other influenza viruses are emerging, performance characteristics may vary.If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. | 609-409-3300 | info@nanoditech.com |
| 00895160002960 | Nano-Check Influenza+COVID-19 Dual Test - The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions.Positive results do not rule out bacterial infection or co-infection with other viruses. | 609-409-3300 | info@nanoditech.com |
| 00895160002991 | Nano-Check™ COVID-19 Antigen Control Kit - Nano-Check™ COVID-19 Antigen Control Kit is an external quality control kit intended for use with the Nano-Check™ COVID-19 Antigen Test. The kit contains one Positive Control Swab and one Negative Control Swab to verify the performance of the test system. The control kit is intended to support routine quality control procedures and should be used according to the instructions for use. This product is not intended for the detection of SARS-CoV-2 in patient specimens and is not for diagnostic use. | 1-855-297-7877 | info@nano-ditech.com |
| 10895160002844 | Nano-Check Influenza+COVID-19 Dual Test - The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The Nano-Check™ Influenza+COVID-19 Dual Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved. | 609-409-3300 | info@nanoditech.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 23866 | 1538789770 | K252283 | Nano-Check Influenza A+B Test | PSZ | 2026-01-15 |
| 23866 | 1787617987 | K243561 | Nano-Check Influenza+COVID-19 Dual Test | SCA | 2025-06-17 |
| 23866 | 2048384802 | K240280 | Nano-Check™ RSV Test | GQG | 2024-07-30 |
| 23866 | 1037261542 | K231187 | Nano-Check™ COVID-19 Antigen Test | QVF | 2024-01-23 |
| 23866 | 1511854044 | K102441 | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN | MMI | 2010-10-20 |
| 23866 | 1962283588 | K102131 | NANO-CHECK AMI CTNI CARDIAC MARKER TEST | MMI | 2010-10-20 |
| 23866 | 1970210135 | K050975 | NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN | MMI | 2006-03-02 |
| 23866 | 1519080960 | K050594 | NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE | LDJ | 2005-05-15 |
| 23866 | 1076155351 | ||||
| 23866 | 1114375954 | ||||
| 23866 | 1153399830 | ||||
| 23866 | 1182141697 | ||||
| 23866 | 1187388412 | ||||
| 23866 | 1206670893 | ||||
| 23866 | 1243238467 | ||||
| 23866 | 1301573669 | ||||
| 23866 | 1352378607 | ||||
| 23866 | 1400672044 | ||||
| 23866 | 1446707366 | ||||
| 23866 | 1604708583 | ||||
| 23866 | 1713775843 | ||||
| 23866 | 1738308145 | ||||
| 23866 | 1775311642 | ||||
| 23866 | 1874031030 | ||||
| 23866 | 1895831359 | ||||
| 23866 | 1903471851 | ||||
| 23866 | 1949950736 | ||||
| 23866 | 2003411209 |
Product Codes Associated With Registrations#
PMN#
Nano-Check? COVID-19 Antigen Test
Nano-Ditech Corporation
NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
NANO-DITECH CORPORATION
NANO-CHECK AMI CTNI CARDIAC MARKER TEST
NANO-DITECH CORPORATION
NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN
NANO-DITECH CO.
NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE
NANO-DITECH CO.
GUDID#
Nano-Check™ COVID-19 Antigen Control Kit - Nano-Check™ COVID-19 Antigen Control Kit is an external quality control kit intended for use with the Nano-Check™ COVID-19 Antigen Test. The kit contains one Positive Control Swab and one Negative Control Swab to verify the performance of the test system. The control kit is intended to support routine quality control procedures and should be used according to the instructions for use. This product is not intended for the detection of SARS-CoV-2 in patient specimens and is not for diagnostic use.
2026-08-07
Fluoro-CheckTM PCT - Fluorescence In Vitro diagnostic test kit for the detection of Procalcitonin in human whole blood, serum or plasma
2016-10-05
Nano-Check™ Influenza A+B Test - The Nano-Check™ Influenza A+B Test is a lateral flow immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B nucleoprotein antigens directly from anterior nasal swab (ANS) samples from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections. The test is not intended for the detection of influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.Performance characteristics for influenza A and B were established during the 2022-2025 influenza seasons when influenza A/H1N1pdm09, influenza A/H3N2, and influenza B/Victoria lineage were the predominant influenza viruses in circulation. When other influenza viruses are emerging, performance characteristics may vary.If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
2026-01-22
Nano-Check™ Influenza A+B Test - The Nano-Check™ Influenza A+B Test is a lateral flow immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B nucleoprotein antigens directly from anterior nasal swab (ANS) samples from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections. The test is not intended for the detection of influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A and B were established during the 2022-2025 influenza seasons when influenza A/H1N1pdm09, influenza A/H3N2, and influenza B/Victoria lineage were the predominant influenza viruses in circulation. When other influenza viruses are emerging, performance characteristics may vary. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
2026-01-22
Nano-Check Influenza+COVID-19 Dual Test - The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions.Positive results do not rule out bacterial infection or co-infection with other viruses.
2026-01-16
Nano-Check Influenza+COVID-19 Dual Test - The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions. Positive results do not rule out bacterial infection or co-infection with other viruses.
2026-01-16
Nano-Check Influenza+COVID-19 Dual Test - The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The Nano-Check™ Influenza+COVID-19 Dual Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved.
2024-08-08
Nano-Check Influenza+COVID-19 Dual Test - The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The Nano-Check™ Influenza+COVID-19 Dual Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved.
2024-08-08
Nano-Check RSV Test - The Nano-Check RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years old, and adults over 60 years of age.
2024-08-08
Nano-Check TM COVID-19 Antigen Test - An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
2024-04-01
Nano-Check TM COVID-19 Antigen Test - An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
2024-04-01
Nano-Check TM COVID-19 Antigen Test - An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. Nano-Check™ COVID-19 Antigen Test is intended for use by medical professionals or operators who are proficient in performing tests.
2020-11-18
Nano-Check™ OPI Test - A rapid, self-controlled, immunoassay for the qualitative detection of Heroin, Codeine, Morphine and Hydrocodone called opiates, in human urine. The detection limit (Cut off concentration) of this test is at 300 ng/ml of morphine.
2023-06-27
Nano-Check™ OPI Test - A rapid, self-controlled, immunoassay for the qualitative detection of Heroin, Codeine, Morphine and Hydrocodone called opiates, in human urine. The detection limit (Cut off concentration) of this test is at 300 ng/ml of morphine.
2023-06-27
Nano-CheckTM COVID-19 IgG/IgM Antibody Test - A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
2020-04-10
Fluoro-CheckTM CRP Test - A in vitro diagnostic test for the quantitative determination of C-reactive protein as an aid in the detection and evaluation of infection, tissue injury, inflammation, and associated diseases.
2020-09-22
Nano-Check TM Strep A Test - A lateral flow immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from human throat swabs specimen collected from symptomatic patients to aid in the diagnosis of Group A Streptococcal infection
2022-03-15
Nano-Check TM CRP plus Test - The rapid immunoassay for the quantitative determination of CRP (C-Reactive protein) in human whole blood, serum, or plasma specimens
2022-03-15
Nano-Check TM COVID-19 IgG Antibody Test - A in vitro diagnostic test for the qualitative detection of IgG antibody against SARS-CoV-2 virus using human blood/serum/plasma samples.
2020-09-22
Fluoro-Check TM COVID-19 Antigen Test - An in vitro diagnostic, a time resolved fluorescence lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
2020-11-25
Nano-CheckTM AMI 2 in 1 - In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human whole blood, serum and plasma
2016-09-14
Nano-CheckTM Nicotine - In Vitro Diagnostic Test kit for the detection of Cotinine in human urine
2016-09-12
Nano-CheckTM Nicotine 500 - In Vitro Diagnostic Test kit for the detection of Cotinine in human urine
2016-10-04
Fluoro-CheckTM cTnI - Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myocardial infarction patients
2016-09-14
Fluoro-CheckTM NT-proBNP - Fluorescence In Vitro Diagnostic Test kit for the determination of NT-proBNP (N-terminal pro-Brain natriuretic peptide) in human whole blood, serum or plasma
2016-10-05
Nano-CheckTM Dengue NS1 - An in vitro diagnostic test for the detection of Dengue NS1 protein in human whole blood of dengue infected patient from acute to convalescent stage.
2017-11-08
Nano-CheckTM PCT - In Vitro Diagnostic Test kit for the determination of Procalcitonin in human whole blood, plasma or serum
2016-09-14
Nano-CheckTM CRP - In Vitro Diagnostic Test kit for the evaluation of CRP in human whole blood, serum or plasma
2016-09-14
Nano-CheckTM hs-CRP - In Vitro Diagnostic Test kit for the evaluation of hs-CRP in human whole blood, plasma or serum
2016-09-14
Nano-CheckTM NT-proBNP - In Vitro Diagnostic Test kit for the determination of NT-proBNP (N-terminal pro-Brain natriuretic peptide) in human whole blood, serum or plasma
2016-09-14
Nano-CheckTM AMI cTnI - In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human whole blood, plasma and serum
2016-09-14
Nano-CheckTM PCT plus - In Vitro Diagnostic Test kit for the determination of Procalcitonin in human whole blood, serum and plasma
2016-09-12
Nano-CheckTM 4 in 1 Test - In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, Creatine kinase MB and Nt-proBNP in human serum and plasma
2016-10-03
Nano-CheckTM D-Dimer - In Vitro Diagnostic Test kit for the evaluation of D-Dimer concentration in human whole blood and plasma
2016-09-14
Nano-CheckTM Dengue IgM/IgG - An in vitro diagnostic test for the detection of anti-Dengue IgM and/or IgG in human whole blood of dengue infected patient from acute to convalescent stage.
2017-11-08
Nano-CheckTM DAT 10M - In Vitro Diagnostic Test kit for the detection of Multi-Drugs in human urine.
2016-09-14
Nano-CheckTM DAT 6M - In Vitro Diagnostic Test kit for the Detection of Multi-Drugs in Human Urine
2016-09-14
Nano-CheckTM DAT 5M - In Vitro Diagnostic Test kit for the detection of muti-drug in human urine.
2018-12-17
Nano-CheckTM DAT 4M - In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Amphetamine, Methamphetamine, and Opiate in human urine.
2018-12-17
Nano-CheckTM DAT 10M - In Vitro Diagnostic Test kit for the detection of Canabinoid, Opiate, Cocaine, Methamphetamine, PCP, MDMA, Barbiturate, methadone, Benzodiazepine, and Amphetamine in human urine.
2018-12-17