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

Status™ COVID
Status™ COVID-19/Flu - 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: QKP

Device Name: Coronavirus Antigen Detection Test System.

Device Class: N

Physical State: In vitro diagnostic device

Definition: The qualitative detection of coronavirus viral antigens directly from clinical specimens.

Submission Type ID: 8

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Antigen detection

Life Sustain Support Flag: N

Unclassified Reason: 11

Implant Flag: N

Target Area: Clinical specimens.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: PSZ

Device Name: Devices Detecting Influenza A, B, And C Virus Antigens

Device Class: 2

Physical State: Devices detecting influenza A, B, and C virus antigens are in vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of influenza virus antigens

Definition: An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A qualitative in vitro diagnostic assay that detects and identifies influenza virus antigens

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: In vitro diagnostic device

Regulation Number: 866.3328

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