Smart DetectTM SARS-CoV-2 rRT-PCR Kit

Basic Information

• Brand Name: Smart DetectTM SARS-CoV-2 rRT-PCR Kit
• Primary DI: B379COV2E0
• Version / Model: COV2-E
• Company Name: INBIOS INTERNATIONAL, INC
• Labeler DUNS: 004006628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-15
• Public Version: 2
• Public Version Date: 2022-11-30
• Public Version Status: Update
• Public Device Record Key: 03a9877d-4b9b-486b-b4ba-74490a3919c7

Device Description

EUA

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: Yes
• 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
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
64747	SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B379COV2E0	HIBCC