Duns Number:249373515
Device Description: Intended for use in the quality control of quantitative coagulation assays, including Prot Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) in the mid-level abnormal range.
Catalog Number
-
Brand Name
VisuCon-F Frozen Coag Screen ABN
Version/Model Number
FCSAB0481
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110432,K110432,K110432
Product Code
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
0b5745f9-2db4-4a15-82fd-4e1063fb489f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 28, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |