SCoV-2 Detect™ Neutralizing Ab ELISA

Basic Information

• Brand Name: SCoV-2 Detect™ Neutralizing Ab ELISA
• Primary DI: B379COVNE1
• Version / Model: COVN-E
• Company Name: INBIOS INTERNATIONAL, INC
• Labeler DUNS: 004006628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: 9707906a-42f0-4c26-94a3-ea76df34c5b4

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QKO	Reagent, Coronavirus Serological	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
65316	SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of neutralizing antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B379COVNE1	HIBCC