Duns Number:156756129
Device Description: Control Solution, AgaMatrix, Combo Normal and High
Catalog Number
-
Brand Name
AgaMatrix
Version/Model Number
8000-03764
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
8f466ef0-8a8d-40cf-afd8-1e31aa1d0489
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
November 04, 2016
Package DI Number
20385543764027
Quantity per Package
48
Contains DI Package
00385543764023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |