FDA.reportPublic FDA data

ROTEM®

Primary DI
04260160470068
Brand
ROTEM®
Company
Tem Innovations GmbH
Model
ap-tem®
Catalog number
503-04-US
Device description
The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. ap-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF).
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JPASystem, Multipurpose For In Vitro Coagulation Studies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101533000EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEMTem Innovations GmbH2011-08-10JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260160470068PrimaryGS10
04260160470488Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260160470068042601604700684260160470068
04260160470488042601604704884260160470488

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor 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 qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
506692297
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260160470327ROTEM®sigma complete + hep5555022022-10-04
04260160470341ROTEM®sigma ROTROL N5552012022-10-04
04260160470358ROTEM®sigma ROTROL P5552022022-10-04
04260160470044ROTEM®in-tem®503-02-US2016-09-16
04260160470075ROTEM®fib-tem®503-06-US2016-09-16
04260160470082ROTEM®hep-tem®503-09-US2016-09-16
04260160470099ROTEM®star-tem® 20503-10-US2016-09-16
04260160470105ROTEM®ROTROL N503-24-US, 503-242016-09-16
04260160470112ROTEM®ROTROL P503-25-US, 503-252016-09-16
04260160470242ROTEM®ex-tem®503-05-US2016-09-16
04260160470600ROTEM®sigma complete + hep5555022022-10-04
04260160470617ROTEM®sigma ROTROL N5552012022-10-04
04260160470624ROTEM®sigma ROTROL P5552022022-10-04
04260160470372ROTEM®sigma2110002022-10-04
04260160470587ROTEM®delta System (US/CA)2010012018-03-15
04260160470020ROTEM®delta System200100-US2016-09-16

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