Duns Number:388240673
Device Description: For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA S For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Catalog Number
B4265-37
Brand Name
Dade® CA System Buffer
Version/Model Number
10873440
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
K050928,K050928
Product Code
KQJ
Product Code Name
SYSTEM, FIBRINOGEN DETERMINATION
Public Device Record Key
c1c5d8ef-203d-4bf7-976d-968c95cafc1e
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 |