- Physicians Office Resource

OSOM Flu SARS
OSOM Flu SARS-CoV-2 Combo Control Kit - 1079

Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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

Device Identifiers

Device Id: 00742860000072

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

Device Id: 50742860100678

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00742860000072

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 10742860000079

Device Type: Unit of Use

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

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