ROTEM® - The FIBTEM assay is a semi-quantitative in vitro - Tem Innovations GmbH

Duns Number:506692297

Device Description: The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thro 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).

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More Product Details

Catalog Number

503-06-US

Brand Name

ROTEM®

Version/Model Number

fib-tem®

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101533,K101533

Product Code Details

Product Code

JPA

Product Code Name

System, Multipurpose For In Vitro Coagulation Studies

Device Record Status

Public Device Record Key

343d62a1-d799-46af-aad7-ead4dd208b3e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEM INNOVATIONS GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6