Status™ COVID-19/Flu A&B Antigen test kit, 25 tests

Status™ COVID
Status™ COVID-19/Flu A&B - BSP-511-25

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from 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 Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: SCA

Device Name: Multi-Analyte Respiratory Virus Antigen Detection Test

Device Class: 2

Physical State: Solid Phase Test Device/Dip-Stick

Definition: A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Multi-Analyte Lateral Flow Immunochromatographic Assay

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Respiratory Clinical Specimens

Regulation Number: 866.3987

Third Party Flag: N

Medical Specialty: MI

Device Id: 10743816001553

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A