Nano-CheckTM COVID-19 IgG/IgM Antibody Test

GUDID 10895160002660

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	10895160002660
NIH Device Record Key	38899c11-c8db-46bd-993b-c54e7eb35130
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nano-CheckTM COVID-19 IgG/IgM Antibody Test
Version Model Number	MD8145
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

Device Issuing Agency	Device ID
GS1	00895160002663 [Primary]
GS1	10895160002660 [Unit of Use]

QKO	Reagent, Coronavirus Serological

Steralize Prior To Use	false
Device Is Sterile	false

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