FDA.reportPublic FDA data

INNOVANCE Heparin UF Control 1

Primary DI
00630414639949
Brand
INNOVANCE Heparin UF Control 1
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873926
Catalog number
10873926
Device description
For quality control of the INNOVANCE® Heparin assay
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GGNPlasma, coagulation control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGNPlasma, Coagulation ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162540000INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbH2017-08-22KFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414639949PrimaryGS10
00630414229515Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414639949006304146399496304146399490630414639949
00630414229515006304142295156304142295150630414229515

GMDN Terms#

Term, Definition table
TermDefinition
Heparin anti-Xa IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
388240673
Device count
5
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
050700024203855-PLASMA Bivalirudin Control5-Diagnostics LtdGGN2026-04-02
08426951011131HemosIL CL Multi-Ab ControlsINSTRUMENTATION LABORATORY COMPANYGGN2025-10-30
00815696021327George King Heparin Control Plasma GEORGE KING BIO-MEDICAL, INCGGN2025-07-11
08718734962724CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962731CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962748CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962755CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962762CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962779CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962786CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962793CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962809CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962816CueSee® CoagEurotrol B.V.GGN2025-04-08
09360136000055Xprecia™ Systems PT ControlsUNIVERSAL BIOSENSORS PTY LTDGGN2024-08-27
08430793242998HEMOSIL RIVAROXABAN CONTROLSINSTRUMENTATION LABORATORY COMPANYGGN2024-07-22
00630414639840INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639857INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639956INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640624ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229522INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229546INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229515INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229539INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019463Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019456Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019005ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640747Control Plasma N Siemens Healthcare Diagnostics Products GmbHGGN2024-02-19
00842768018909Control Plasma N Siemens Healthcare Diagnostics Products GmbHGGN2024-02-19