FDA.reportPublic FDA data

Asserachrom® tPA

Primary DI
03607450009484
Brand
Asserachrom® tPA
Company
DIAGNOSTICA STAGO
Model
00948
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GGPTEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGPTest, Qualitative And Quantitative Factor DeficiencyHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971519000ASSERACHROM TPA TEST KITAmerican Bioproducts Co.1997-08-19GGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607450009484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607450009484036074500094843607450009484

GMDN Terms#

Term, Definition table
TermDefinition
Tissue plasminogen activator IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of tissue plasminogen activator in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262277122
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607450006766STA® - Coag Control N + ABN006762016-09-15
03607450006773STA® - Coag Control (N + ABN) PLUS006772016-09-15
03607450006780STA® - System Control N + P006782016-09-15
03607450005264STA® - Liatest® Control N + P005262016-09-15
13607450006756STA® - Unicalibrator006752016-09-15
13607450011392Pool Norm011392016-09-15
03607450005400FDP Plasma005402016-09-15
13607450005414FDP Plasma (Latex)005412016-09-15
13607450005513FDP Plasma (Buffer)005512016-09-15
13607450006749STA® - Fibrinogen 5006742016-09-15
03607450589894STA Compact Max® (with cap piercing option)589892016-09-15
03607450589900STA Compact Max®589902016-09-15
03607450590265STA R Max®590262018-10-30
03607450590272STA R Max® (with cap piercing option)590272018-10-30
13607450009757STA® - Desorb U009752020-09-24
03607450009736STA® - Cleaner Solution009732020-09-29
13607450003601STA® - Owren-Koller003602018-09-24
03607450000030STA Coag Expert®V8871112022-12-09
03607450000047Coag.One server licenseV8867652022-12-09
03607450867657Coag.One server licenseV7867652022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843876000602CRYOcheck Factor VIII ChromogenicPrecision Biologic IncGGP2025-11-25
00630414320366BC von Willebrand ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-09-12
00842768018800BC von Willebrand ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-09-12
00195226001129HemosIL Chromogenic Factor IXINSTRUMENTATION LABORATORY COMPANYGGP2024-07-09
00630414640433vWF AgSiemens Healthcare Diagnostics Products GmbHGGP2024-03-29
00630414639437Berichrom a2-AntiplasminSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639628Berichrom Protein CSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639710Berichrom Protein CSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639826INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640389Factor VIII Chromogenic AssaySiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640457Protein S AcSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640655Protein C ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00842768006661vWF AgSiemens Healthcare Diagnostics Products GmbHGGP2023-06-16
00843876000565CRYOcheck Chromogenic Factor IXPrecision Biologic IncGGP2023-01-06
G0561012580Lyophilized Platelets Bio/Data CorporationGGP2022-03-23
G0561012691vW Normal Reference PlasmaBio/Data CorporationGGP2022-03-23
G0561012701vW Abnormal Control PlasmaBio/Data CorporationGGP2022-03-23
G0561015951Lyophilized Platelets Bio/Data CorporationGGP2022-03-23
G0561030251vW Factor Assay (Ristocetin Cofactor)Bio/Data CorporationGGP2022-03-23
G0561064261vW Normal Control PlasmaBio/Data CorporationGGP2022-03-23
G0561067301vW Select Kit (Ristocetin Cofactor)Bio/Data CorporationGGP2022-03-23
00843876000558CRYOcheck Factor VIII ChromogenicPrecision Biologic IncGGP2020-07-27
08600000686048VFERamco Laboratories, Inc.GGP2019-03-26
00843876000503CRYOcheck™ FVIII Inhibitor KitPrecision Biologic IncGGP2019-03-25
00842768039522INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHGGP2018-11-15
03607450007374STA® - Staclot® Protein C 3DIAGNOSTICA STAGOGGP2017-12-06
10629009010000VisuLize Factor FVIII Antigen KitAffinity Biologicals IncGGP2017-04-28
10629009020009VisuLize Factor FIX Antigen KitAffinity Biologicals IncGGP2017-04-28
00859394006095ThromboTek PSeR 2 DIAGNOSTICS, INC.GGP2016-11-15
00811476010000Chrono-logCHRONO-LOG CORPGGP2016-10-11