STA® - Liatest® VWF:Ag - 00518
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of coagulation factor VIII-associated antigen, also known as von Willebrand antigen, in a clinical specimen using a nephelometry/turbidimetry method. It is typically used in the diagnosis of congenital or acquired von Willebrand's disease.
Environmental Conditions
- 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: GJT
Device Name: Plasma, Coagulation Factor Deficient
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
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: 864.7290
Third Party Flag: Y
Medical Specialty: HE
Device IdentifiersDevice Id: 03607450005189
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