Duns Number:388240673
Device Description: Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range
Catalog Number
B4233-22
Brand Name
Dade® Data-Fi® Abnormal Fibrinogen Control
Version/Model Number
10445719
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
K811069,K811069
Product Code
KQJ
Product Code Name
SYSTEM, FIBRINOGEN DETERMINATION
Public Device Record Key
ead29129-8277-4587-a17d-991b77ce14f1
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
September 24, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |