FDA.reportPublic FDA data

Dade Ci-Trol Heparin Control, Low

Primary DI
00630414640259
Brand
Dade Ci-Trol Heparin Control, Low
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873833
Catalog number
10873833
Device description
Control in heparin assay procedures
Published
2024-03-25
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
KFFAssay, heparin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFFAssay, HeparinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K812424000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K812424000CI-TROL HEPARIN CONTROLS, LOW/HIGHAmerican Dade1981-10-02KFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414640259PrimaryGS10
00842768019548Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414640259006304146402596304146402590630414640259
00842768019548008427680195488427680195480842768019548

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) 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
10
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
00630414640365Dade Ci-Trol Heparin Control, HighSiemens Healthcare Diagnostics Products GmbHKFF2024-03-25
00630414639864INNOVANCE HeparinSiemens Healthcare Diagnostics Products GmbHKFF2024-03-25
00842768019548Dade Ci-Trol Heparin Control, LowSiemens Healthcare Diagnostics Products GmbHKFF2024-03-25
00842768019531Dade Ci-Trol Heparin Control, HighSiemens Healthcare Diagnostics Products GmbHKFF2024-03-25
00842768017438INNOVANCE HeparinSiemens Healthcare Diagnostics Products GmbHKFF2017-09-11
03663537008191BIOPHEN HEPARIN 6HYPHEN BIOMEDKFF2017-03-08
00842768003899Dade® Ci-Trol® Heparin Control, LowSiemens Healthcare Diagnostics Products GmbHKFF2016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, HighSiemens Healthcare Diagnostics Products GmbHKFF2016-09-24
00842768012945Berichrom® HeparinSiemens Healthcare Diagnostics Products GmbHKFF2016-09-24
08426950042211HemosIL HeparinINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
08426950580324HemosIL Liquid Anti-XaINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
08426950088196Coatest HeparinINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
08426950088967Coamatic HeparinINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
08426950472476HemosIL Liquid HeparinINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
08426950472490HemosIL LMW Heparin ControlsINSTRUMENTATION LABORATORY COMPANYKFF2016-09-23
10711234102176Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
10711234202036Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
10711234202081Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
10711234202098Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
10711234202104Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
10711234202111Hemochron Whole Blood Coagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.KFF2016-09-22
00850201006031ACTICHROME Heparin (Anti-FIIa)Biomedica ADI Inc.KFF2016-09-20
00850201006079ACTICHROME HEPARIN (ANTI-FXA)Biomedica ADI Inc.KFF2016-09-20
03607450006827STA® - HBPM/LMWH ControlDIAGNOSTICA STAGOKFF2016-09-15
03607450006841STA® - Hepanorm® HDIAGNOSTICA STAGOKFF2016-09-15
03607450006810STA® - Hepanorm® HBPM/LMWHDIAGNOSTICA STAGOKFF2016-09-15
03607450011791STA® - Liquid Anti-Xa 8DIAGNOSTICA STAGOKFF2016-09-15
03607450009064Stachrom® HeparinDIAGNOSTICA STAGOKFF2016-09-15
03607450006834STA® - Heparin ControlDIAGNOSTICA STAGOKFF2016-09-15
03607450011784STA® - Liquid Anti-Xa 4DIAGNOSTICA STAGOKFF2016-09-15