FDA.reportPublic FDA data

Dade Actin FSL Activated PTT Reagent

Primary DI
00630414640358
Brand
Dade Actin FSL Activated PTT Reagent
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873832
Catalog number
10873832
Device description
Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
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
GGWTEST, TIME, PARTIAL THROMBOPLASTIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGWTest, Time, Partial ThromboplastinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863594000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863594000ACTIN FSL ACTIVATED PTT REAGENTAmerican Dade1986-10-17GGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414640358PrimaryGS10
00842768019555Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414640358006304146403586304146403580630414640358
00842768019555008427680195558427680195550842768019555

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

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
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
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414640242Dade Actin FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414640327Dade Actin FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414640341Dade Actin FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414639758Factor V LeidenSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00842768019562Dade Actin FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00842768019555Dade Actin FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
13607450012627PTT-LADIAGNOSTICA STAGOGGW2021-03-23
03607450012620PTT-LADIAGNOSTICA STAGOGGW2021-03-23
07640175460013PefakitPentapharm AGGGW2017-01-25
10859394006016Phospholin ES w/ Calcium ChlorideR 2 DIAGNOSTICS, INC.GGW2016-11-15
10859394006146LupoTek KCTR 2 DIAGNOSTICS, INC.GGW2016-11-15
10859394006238Phospholin ES w/CalciumR 2 DIAGNOSTICS, INC.GGW2016-11-15
00842768003844Dade® Actin® FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768003868Dade® Actin® FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768003875Dade® Actin® FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768003882Dade® Actin® FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768033520Factor V LeidenSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
08426950076100Coatest APC Resistance V-SINSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950060017Coatest APC Resistance VINSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950060147Coatest APC ResistanceINSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950062424HemosIL Factor V Leiden (APC Resistance V)INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950087656HemosIL Factor V Reagent Plasma (for APC R V)INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950088912Coatest APCR Control Plasma Level 1INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950088929Coatest APCR Control Plasma Level 2INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
00843876000435CRYOcheck™ Platelet LysatePrecision Biologic IncGGW2016-09-23
00850201006192ACTICLOT Protein C Resistance KitBiomedica ADI Inc.GGW2016-09-20
03607450005974STA® - C.K. Prest® 5DIAGNOSTICA STAGOGGW2016-09-15
13607450005957STA® - PTT A 5DIAGNOSTICA STAGOGGW2016-09-15
13607450005995PTT-LADIAGNOSTICA STAGOGGW2016-09-15
M52551870AB-TROL 2 Coagulation ControlHELENA LABORATORIES CORPORATIONGGW2016-09-07