- Physicians Office Resource

INNOVANCE Apixaban Standards
INNOVANCE Apixaban Standards - 10873675

Device Description

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of activated coagulation factor Xa inhibitor in a clinical specimen.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

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: 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 Identifiers

Device Id: 00630414240343

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

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