FDA.reportPublic FDA data

Pathromtin® SL

Primary DI
00842768007538
Brand
Pathromtin® SL
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10446067
Catalog number
OQGS35
Device description
Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Published
2016-09-24
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
GFOACTIVATED PARTIAL THROMBOPLASTIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFOActivated Partial ThromboplastinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955450000PATHROMTIN SLBehring Diagnostics, Inc.1996-04-19GFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768007538PrimaryGS10
00842768019074Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768007538008427680075388427680075380842768007538
00842768019074008427680190748427680190740842768019074

GMDN Terms#

Term, Definition table
TermDefinition
Activated partial thromboplastin time (APTT) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the activated partial thromboplastin time (APTT) of 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)242-3233XX@XX.XX
+1(800)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
20
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
00630414640310Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640334Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640709Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640716Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00842768019579Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00842768019074Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00850053916199IDG/SanzayIDG/SANZAY CorporationGFO2024-01-12
00843876000596CRYOcheck Hex LAPrecision Biologic IncGFO2023-05-02
00843876000510CRYOcheck Hex LA Precision Biologic IncGFO2020-11-05
00843876000527CRYOcheck Hex LAPrecision Biologic IncGFO2020-11-05
00817869020014Slide Platelet Aggregation Test ReagentANALYTICAL CONTROL SYSTEMS INCGFO2019-01-31
00842768003837Dade® Actin® Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768003851Dade® Actin® Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768007521Pathromtin® SLSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
08426950087649HemosIL SynthAFaxINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950433491HemosIL Silica Clotting TimeINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950023487HemosIL Calcium Chloride 0.025M (for APTT-SP kit)INSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950078920HemosIL SynthASilINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950078937HemosIL APTT-SPINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950915676GEM TEST APTT CITRATEINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950087632HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax)INSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
00627944000097QuikCoag Calcium Chloride 0.02MBiomedica Diagnostics IncGFO2016-09-22
00627944000103QuikCoag Calcium Choride 0.02MBiomedica Diagnostics IncGFO2016-09-22
10711234103029Hemochron Whole Blood Microcoagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.GFO2016-09-22
00627944000042QuikCoag APTT-EABiomedica Diagnostics IncGFO2016-09-22
00627944000059QuikCoag APTT-EABiomedica Diagnostics IncGFO2016-09-22
10627944000094QuikCoag Calcium Chloride 0.02MBiomedica Diagnostics IncGFO2016-09-22
10627944000100QuikCoag Calcium Choride 0.02MBiomedica Diagnostics IncGFO2016-09-22
00845275000511Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGFO2016-09-16
00845275000641Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGFO2016-09-16