VITROS Immunodiagnostic Products SARS
VITROS - 6199944
Device Description
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).
Environmental Conditions
- Do not freeze
- 8.00
- 2.00
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 IdentifiersDevice 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