| Primary Device ID | 10895160002790 |
| NIH Device Record Key | d13acc36-c719-48dd-908b-bb0a04227b52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fluoro-Check TM COVID-19 Antigen Test |
| Version Model Number | TF-8150 |
| Company DUNS | 126544316 |
| Company Name | NANO-DITECH CORPORATION |
| Device Count | 20 |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com | |
| Phone | 1-609-406-3300 |
| info@nanoditech.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00895160002793 [Primary] |
| GS1 | 10895160002790 [Unit of Use] |
| QMN | Covid-19 Multi-Analyte Antigen Device |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-03 |
| Device Publish Date | 2020-11-25 |
| 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 |
| 00895160002366 - Nano-CheckTM Nicotine 500 | 2023-06-29 In Vitro Diagnostic Test kit for the detection of Cotinine in human urine |
| 00895160002410 - Fluoro-CheckTM cTnI | 2023-06-29 Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myoc |