Nano-Check TM COVID-19 Antigen Test MD-8147 2T

GUDID 10895160002868

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 ID10895160002868
NIH Device Record Key50465b62-83c6-4366-8e83-110231009a43
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano-Check TM COVID-19 Antigen Test
Version Model NumberMD-8147
Catalog NumberMD-8147 2T
Company DUNS126544316
Company NameNANO-DITECH CORPORATION
Device Count2
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 Perscriptiontrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002861 [Primary]
GS110895160002868 [Unit of Use]

FDA Product Code

QMNCovid-19 Multi-Analyte Antigen Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-09
Device Publish Date2024-04-01

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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