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

GUDID 10895160002868

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Primary Device ID	10895160002868
NIH Device Record Key	50465b62-83c6-4366-8e83-110231009a43
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nano-Check TM COVID-19 Antigen Test
Version Model Number	MD-8147
Catalog Number	MD-8147 2T
Company DUNS	126544316
Company Name	NANO-DITECH CORPORATION
Device Count	2
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	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00895160002861 [Primary]
GS1	10895160002868 [Unit of Use]

QMN	Covid-19 Multi-Analyte Antigen Device

Steralize Prior To Use	false
Device Is Sterile	false

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