RSV Antigen Test (12/kt, 48kt/cs)

RSV Antigen Test (12/kt, 48kt/cs)
McKesson - RSV001

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from respiratory syncytial virus (RSV) in a clinical specimen.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GQG

Device Name: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3480

Third Party Flag: N

Medical Specialty: MI

Device Id: 00612479269897

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00612479269880

Package Quantity: 48

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 00612479269880

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: 00612479269873

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