FDA.reportPublic FDA data

INNOVANCE Anti-Xa

Primary DI
00630414240404
Brand
INNOVANCE Anti-Xa
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873681
Catalog number
OPPU05
Device description
In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma.
Published
2024-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00630414240404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414240404006304142404046304142404040630414240404

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor Xa inhibitor/heparin activity reagent kit IVDA 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).

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
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
00195226000016HemosIL Liquid Anti-XaINSTRUMENTATION LABORATORY COMPANYQLU2021-03-15
00195226000054HemosIL Liquid Anti-XaINSTRUMENTATION LABORATORY COMPANYQLU2021-03-15