FDA.reportPublic FDA data

ROTEM®

Primary DI
04260160470075
Brand
ROTEM®
Company
Tem Innovations GmbH
Model
fib-tem®
Catalog number
503-06-US
Device description
The FIBTEM 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 platelet contribution to the clot firmness. fib-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameter 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
04260160470075PrimaryGS10
04260160470495Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260160470075042601604700754260160470075
04260160470495042601604704954260160470495

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
04260160470068ROTEM®ap-tem®503-04-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000558185CLOTtrac™MEDTRONIC, INC.JPA2026-02-22
00763000558291RACTMEDTRONIC, INC.JPA2026-02-22
20763000558189CLOTtrac™MEDTRONIC, INC.JPA2026-02-22
20763000558295RACTMEDTRONIC, INC.JPA2026-02-22
04987562499700Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONJPA2025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONJPA2025-12-19
08426951011223HemosIL CL TriggersINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08426951326594HemosIL CL Rinse solutionINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08430793045476ACL TOP 970 CLINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08430793058322HemosIL CL Probe ConditionerINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
04987562499687Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
10812747018531Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
20812747018538Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
00630414639772Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00630414640563Calcium Chloride SolutionSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00842768018893Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00842768018916Calcium Chloride SolutionSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
04987562518654Automated Blood Coagulation Analyzer CS-5100SYSMEX CORPORATIONJPA2024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500SYSMEX CORPORATIONJPA2024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONJPA2024-02-22
00810149090622R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149091681R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092619R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092626R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092749R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149093258R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149095542R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149096969R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
G0561009910Tris Buffered SalineBio/Data CorporationJPA2023-08-30