| Primary Device ID | 00895160002496 |
| NIH Device Record Key | 84d4197f-0af9-4868-9802-16b03495cdd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fluoro-CheckTM AMI 3 in 1 |
| Version Model Number | TF3154 |
| Catalog Number | TF3154 |
| 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 | 609-409-3300 |
| info@nanoditech.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00895160002496 [Primary] |
| GS1 | 10895160002493 [Unit of Use] |
| MMI | Immunoassay Method, Troponin Subunit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-03 |
| Device Publish Date | 2019-05-24 |
| 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 |
| 00895160002427 - Fluoro-CheckTM PCT | 2023-06-29 Fluorescence In Vitro diagnostic test kit for the detection of Procalcitonin in human whole blood, serum or plasma |
| 00895160002434 - Fluoro-CheckTM NT-proBNP | 2023-06-29 Fluorescence In Vitro Diagnostic Test kit for the determination of NT-proBNP (N-terminal pro-Brain natriuretic peptide) in human |