Nano-Check TM COVID-19 IgG Antibody Test

Basic Information

• Brand Name: Nano-Check TM COVID-19 IgG Antibody Test
• Primary DI: 00895160002724
• Version / Model: MD8146
• Company Name: NANO-DITECH CORPORATION
• Labeler DUNS: 126544316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 3
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 469044a7-38cd-4020-b7e4-37092a5de77e

Device Description

A in vitro diagnostic test for the qualitative detection of IgG antibody against SARS-CoV-2 virus using human blood/serum/plasma samples.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
64831	SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin G (IgG) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10895160002721	GS1
Primary	00895160002724	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]