FDA.reportPublic FDA data

INNOVANCE Apixaban Controls

Primary DI
00630414321837
Brand
INNOVANCE Apixaban Controls
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10874082
Catalog number
10874082
Device description
For quality control of the INNOVANCE ANTI-XA assay for the quantitativedetermination of apixaban in citrated human plasma.
Published
2025-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240315000INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)Siemens Healthcare Diagnostics Products GmbH2024-10-10QLU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414321837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414321837006304143218376304143218370630414321837

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor Xa inhibitor IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of activated coagulation factor Xa inhibitor in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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