VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Extraction Buffer

VITROS Immunodiagnostic Products SARS
VITROS - 6199944

A buffered solution intended to be used for the processing and preparation of a clinical specimen, for subsequent in vitro diagnostic testing, by extraction of specific target analytes present in the clinical specimen (e.g., proteins, antigens).

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

Device Id: 10758750033577

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