FDA.reportPublic FDA data

ARK™ Apixaban Assay

Primary DI
00812101031230
Brand
ARK™ Apixaban Assay
Company
ARK DIAGNOSTICS INC
Model
5047-0001-00
Catalog number
5047-0001-00
Device description
The ARK™ Apixaban Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of apixaban in 3.2% citrated human plasma on automated clinical chemistry analyzers. Apixaban concentrations can be used as an aid in management of patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information: patients at risk for major bleeding, patient experiencing a bleeding episode. The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings. For use in adult population.
Published
2026-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QLUAnti-Factor Xa Activity Test System, Apixaban

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLUAnti-Factor Xa Activity Test System, ApixabanHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812101031230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812101031230008121010312308121010312300812101031230

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor Xa inhibitor IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of activated coagulation factor Xa inhibitor in a clinical specimen, using a clotting method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
5102706270customersupport@ark-tdm.com

Regulatory Flags#

DUNS number
164880598
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812101031247ARK™ Apixaban Calibrator5047-0002-005047-0002-002026-09-25
00812101031254ARK™ Apixaban Control5047-0003-005047-0003-002026-09-25
00858724003414ARK™ Fentanyl Calibrator5031-0002-005031-0002-002017-04-30
00812101031599ARK™ Ketamine II Assay5083-0001-005083-0001-002025-12-27
00812101031605ARK™ Ketamine II Assay5083-0001-015083-0001-002025-12-27
00812101031612ARK™ Ketamine II Assay5083-0001-025083-0001-022025-12-27
00812101031629ARK™ Ketamine II Calibrator5083-0002-005083-0002-002025-12-27
00812101031636ARK™ Ketamine II Calibrator (Negative)5083-0002-015083-0002-012025-12-27
00812101031643ARK™ Ketamine II Calibrator (50 ng/mL Cutoff)5083-0002-025083-0002-022025-12-27
00812101031650ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)5083-0002-035083-0002-032025-12-27
00812101031667ARK™ Ketamine II Control (25/75)5083-0003-005083-0003-002025-12-27
00812101031674ARK™ Ketamine II Control (75/125)5083-0003-015083-0003-012025-12-27
00812101031995ARK™ Ketamine II Assay5083-0001-035083-0001-032025-12-27
00812101031001DRI Tramadol Assay - 500 mLB40000350B400003502024-11-14
00812101031018DRI Tramadol Assay - 115mLB40000351B400003512024-11-14
00812101031025DRI Tramadol Negative Calibrator KitB40000353B400003532024-11-14
00812101031032DRI Tramadol Cutoff Calibrator KitB40000352B400003522024-11-14
00812101031049DRI Tramadol Calibrator KitB40000366B400003662024-11-14
00812101031056DRI Tramadol Control KitB40000354B400003542024-11-14
00812101031469ARK Levetiracetam II Assay 5070-0001-015070-0001-012024-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414321837INNOVANCE Apixaban ControlsSiemens Healthcare Diagnostics Products GmbHQLU2025-07-18
00630414321844INNOVANCE Apixaban StandardSiemens Healthcare Diagnostics Products GmbHQLU2025-07-18
00630414640204INNOVANCE Anti-XaSiemens Healthcare Diagnostics Products GmbHQLU2025-07-18
00630414240336INNOVANCE Apixaban ControlsSiemens Healthcare Diagnostics Products GmbHQLU2024-11-26
00630414240343INNOVANCE Apixaban StandardsSiemens Healthcare Diagnostics Products GmbHQLU2024-11-26
00630414240404INNOVANCE Anti-XaSiemens Healthcare Diagnostics Products GmbHQLU2024-11-26
00195226000016HemosIL Liquid Anti-XaINSTRUMENTATION LABORATORY COMPANYQLU2021-03-15
00195226000054HemosIL Liquid Anti-XaINSTRUMENTATION LABORATORY COMPANYQLU2021-03-15