Nano-Check TM COVID-19 Antigen Test

GUDID 10895160002783

An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.

NANO-DITECH CORPORATION

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Primary Device ID10895160002783
NIH Device Record Key49073bbf-ad92-44cf-886a-db1a2881beb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano-Check TM COVID-19 Antigen Test
Version Model NumberMD-8147
Company DUNS126544316
Company NameNANO-DITECH CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002786 [Primary]
GS110895160002783 [Unit of Use]
GS120895160002780 [Package]
Contains: 00895160002786
Package: Kit [2 Units]
In Commercial Distribution

FDA Product Code

QMNCovid-19 Multi-Analyte Antigen Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-10
Device Publish Date2020-11-18

On-Brand Devices [Nano-Check TM COVID-19 Antigen Test]

10895160002783An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid an
10895160002868An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid an
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