Primary Device ID | 00895160002403 |
NIH Device Record Key | d67df70c-cec6-4f21-9a13-25569e581067 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fluoro-CheckerTM TRF Reader |
Version Model Number | TRF |
Catalog Number | TF101 |
Company DUNS | 126544316 |
Company Name | NANO-DITECH CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com | |
Phone | 1-609-409-3300 |
info@nanoditech.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00895160002403 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-08 |
Device Publish Date | 2019-03-29 |
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 |