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).
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
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
JPA
Product Code Name
System, Multipurpose For In Vitro Coagulation Studies
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |