NANO-DITECH CORPORATION

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• nanoditech.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Nano-Check? RSV Test

  2024-07-30

  Nano-Ditech Corporation

• Nano-Check? COVID-19 Antigen Test

  2024-01-23

  Nano-Ditech Corporation

• NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN

  2010-10-20

  NANO-DITECH CORPORATION

• NANO-CHECK AMI CTNI CARDIAC MARKER TEST

  2010-10-20

  NANO-DITECH CORPORATION

• NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN

  2006-03-02

  NANO-DITECH CO.

• NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE

  2005-05-15

  NANO-DITECH CO.

GUDID#

• Fluoro-CheckTM PCT - Fluorescence In Vitro diagnostic test kit for the detection of Procalcitonin in human whole blood, serum or plasma

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  2026-01-16

• 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.

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  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-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  2023-06-27

• Fluoro-CheckerTM TRF Reader - Analyzer for Fluoro-CheckTM line of diagnostic products.

  NANO-DITECH CORPORATION

  2019-03-29

• Nano-CheckerTM 710 Reader - Analyzer for Nano-CheckTM line of diagnostic products.

  NANO-DITECH CORPORATION

  2019-03-29

• Nano-CheckTM DAT 10M - In Vitro Diagnostic Test kit for the detection of Canabinoid, K2, Cocaine, Methamphetamine, PCP, MDMA, Ketamine, Barbiturate, Benzodiazepine, and Amphetamine in human urine.

  NANO-DITECH CORPORATION

  2019-04-15

• Nano-CheckTM DAT 4M - In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Amphetamine, Methamphetamine, and MDMA in human urine.

  NANO-DITECH CORPORATION

  2019-04-15

• Nano-CheckTM DAT 10M - In Vitro Diagnostic Test kit for the detection of muti-drugs n human urine.

  NANO-DITECH CORPORATION

  2019-05-03

• Fluoro-CheckTM beta-hCG - An in vitro diagnostic test for the determination of beta-Human chorionic gonadotropin in human whole blood, serum, and plasma.

  NANO-DITECH CORPORATION

  2018-04-25

• Fluoro-CheckTM iFOB - An in vitro diagnostic test for the detection of fecal occult blood (FOB) in human fecal samples.

  NANO-DITECH CORPORATION

  2019-05-24

• Fluoro-CheckTM Vitamin D - An in vitro diagnostic test for the determination of vitamin D in human serum and plasma specimen.

  NANO-DITECH CORPORATION

  2019-05-24

• Fluoro-CheckTM Influenza A+B - An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.

  NANO-DITECH CORPORATION

  2019-05-24

• Fluoro-CheckTM D-Dimer - In Vitro Diagnostic Test kit for the evaluation of D-Dimer concentration in human whole blood and plasma

  NANO-DITECH CORPORATION

  2019-05-24

• Nano-CheckTM DAT 6M - In Vitro Diagnostic Test kit for the detection of Multi-Drugs in human urine.

  NANO-DITECH CORPORATION

  2019-07-03

• Nano-CheckTM DAT 6M - In Vitro Diagnostic Test kit for the detection of multi-drugs in human urine.

  NANO-DITECH CORPORATION

  2019-07-03

• Nano-CheckTM Malaria - An in vitro diagnostic test for the detection of malaria HRP2 (histidine-rich protein 2) of Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) of Plasmodium vivax in human whole blood as an aid in the diagnosis of malaria infection.

  NANO-DITECH CORPORATION

  2017-05-04

• Fluoroo-Check Heating Block - The Fluoro-Check TM Heating Block is an anti-temperature preservation device designed to obtain optimal temperature from reagents.The compact Digital-controlled Heating Block provides excellent space utilization and superior product quality.

  NANO-DITECH CORPORATION

  2020-02-20

• 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.

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  2018-12-17

• Nano-CheckTM DAT 5M - In Vitro Diagnostic Test kit for the detection of muti-drug in human urine.

  NANO-DITECH CORPORATION

  2018-12-17

• Nano-CheckTM DAT 6M - In Vitro Diagnostic Test kit for the Detection of Multi-Drugs in Human Urine

  NANO-DITECH CORPORATION

  2016-09-14

• Nano-CheckTM DAT 10M - In Vitro Diagnostic Test kit for the detection of Multi-Drugs in human urine.

  NANO-DITECH CORPORATION

  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.

  NANO-DITECH CORPORATION

  2017-11-08

• Nano-CheckTM D-Dimer - In Vitro Diagnostic Test kit for the evaluation of D-Dimer concentration in human whole blood and plasma

  NANO-DITECH CORPORATION

  2016-09-14

• 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

  NANO-DITECH CORPORATION

  2016-10-03

• Nano-CheckTM PCT plus - In Vitro Diagnostic Test kit for the determination of Procalcitonin in human whole blood, serum and plasma

  NANO-DITECH CORPORATION

  2016-09-12

• Nano-CheckTM AMI cTnI - In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human whole blood, plasma and serum

  NANO-DITECH CORPORATION

  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

  NANO-DITECH CORPORATION

  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

  NANO-DITECH CORPORATION

  2016-09-14

• Nano-CheckTM CRP - In Vitro Diagnostic Test kit for the evaluation of CRP in human whole blood, serum or plasma

  NANO-DITECH CORPORATION

  2016-09-14

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