Primary Device ID | 00895160002472 |
NIH Device Record Key | 5f849588-fdfb-478b-97b9-93c43b719c35 |
Commercial Distribution Discontinuation | 2022-12-31 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Nano-CheckTM Dengue NS1 |
Version Model Number | MD8143 |
Catalog Number | MD8143 |
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 | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com | |
Phone | 855-297-7877 |
info@nanoditech.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00895160002472 [Primary] |
GS1 | 10895160002479 [Unit of Use] |
OSU | Dengue Serological Reagents |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2023-06-29 |
Device Publish Date | 2017-11-08 |
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 |