Nano-Check™ Influenza A+B Test
GUDID 10895160002875
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
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical| Primary Device ID | 10895160002875 |
| NIH Device Record Key | 8cdd0aa7-bdbd-48e6-b4c5-2c9c41669e75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nano-Check™ Influenza A+B Test |
| Version Model Number | MD8153 |
| Company DUNS | 126544316 |
| Company Name | NANO-DITECH CORPORATION |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com | |
| Phone | 609-409-3300 |
| info@nanoditech.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00895160002878 [Primary] |
| GS1 | 10895160002875 [Unit of Use] |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-30 |
| Device Publish Date | 2026-01-22 |
Devices Manufactured by NANO-DITECH CORPORATION
| 10895160002875 - Nano-Check™ Influenza A+B Test | 2026-01-30The 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. |
| 10895160002875 - Nano-Check™ Influenza A+B Test | 2026-01-30 The Nano-Check™ Influenza A+B Test is a lateral flow immuno-chromatographic assay intended for the qualitative detection of in |
| 10895160002967 - Nano-Check Influenza+COVID-19 Dual Test | 2026-01-26 The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detect |
| 10895160002844 - Nano-Check Influenza+COVID-19 Dual Test | 2024-08-16 The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simult |
| 00895160002854 - Nano-Check RSV Test | 2024-08-16 The Nano-Check RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV |
| 10895160002868 - Nano-Check TM COVID-19 Antigen Test | 2024-04-09 An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. |
| 10895160002240 - Nano-Check™ OPI Test | 2023-07-05 A rapid, self-controlled, immunoassay for the qualitative detection of Heroin, Codeine, Morphine and Hydrocodone called opiates, |
| 00895160002120 - Nano-CheckTM AMI 2 in 1 | 2023-06-29 In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human whole blood, serum and plasma |
| 00895160002359 - Nano-CheckTM Nicotine | 2023-06-29 In Vitro Diagnostic Test kit for the detection of Cotinine in human urine |
Trademark Results [Nano-Check]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NANO-CHECK 88099913 not registered Live/Pending |
Nano-Ditech Corporation 2018-08-30 |
 NANO-CHECK 78895879 3610468 Dead/Cancelled |
Nano-Ditech Corporation 2006-05-30 |
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