F.S. Test

F.S. Test - 00857

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of soluble fibrin monomer complexes in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test typically used as an aid in the diagnosis of disseminated intravascular coagulation (DIC). It is not intended to be used for self-testing.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JBN

Device Name: Fibrin Monomer Paracoagulation

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 864.7300

Third Party Flag: N

Medical Specialty: HE

Device Id: 03607450008579

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