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
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
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24

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