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INNOVANCE Apixaban Standard

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
INNOVANCE Apixaban Standard FDA UDI
Generic Name
Coagulation factor Xa inhibitor IVD, calibrator FDA UDI
Device Name
For calibration of the INNOVANCE ANTI-XA assay for the quantitativedetermination of the concentration of apixaban in citrated human plasma. FDA UDI
Model / Reference
10874083 FDA UDI
Description
For calibration of the INNOVANCE ANTI-XA assay for the quantitativedetermination of the concentration of apixaban in citrated human plasma. FDA UDI

Identifiers

Catalog Number
10874083 FDA UDI
Primary DI / UDI-DI
00630414321844 FDA UDI
510(k) Number
K240315 FDA UDI
FDA Product Code
QLU FDA UDI
GMDN Term
Coagulation factor Xa inhibitor IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7295 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coagulation factor Xa inhibitor IVD, calibrator

INNOVANCE Apixaban Standard by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation factor Xa inhibitor IVD, calibrator.

Cleared under the same submission

K240315 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI 4ccbe51b-7f06-4630-acaa-4515e4c8fce3 37 fields · synced Jun 8, 2026