In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma.

In
INNOVANCE Anti-Xa - 10873681

A collection of reagents intended to be used for the quantitative detection of heparin activity by measuring the ability of heparin to inhibit activated coagulation factor X (factor Xa) and for the qualitative and/or quantitative detection of factor Xa inhibitors, in a clinical specimen. The assay is used to monitor anticoagulation therapy with heparin and/or as an aid to diagnose/determine anticoagulant status during therapy with factor Xa direct inhibitors (e.g., rivaroxaban, apixaban).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QLU

Device Name: Anti-Factor Xa Activity Test System, Apixaban

Device Class: 2

Physical State: Anti-factor Xa activity test system containing reagents, drug-specific calibrators and controls

Definition: A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings.

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The test detects residual factor Xa using a chromogenic substrate. The signal or optical density is compared to a drug-specific calibration curve and results are reported as nanograms per milliliter (ng/mL). The test may utilize other technologies and/or detection methods.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral human whole blood (citrated plasma)

Regulation Number: 864.7295

Third Party Flag: N

Medical Specialty: HE

Device Id: 00630414240404

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