Duns Number:141608724
Device Description: ACCU-CHEK GUIDE 2-LEVEL CONTROLS US
Catalog Number
-
Brand Name
ACCU-CHEK GUIDE
Version/Model Number
07748906001
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
-
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
81115b25-695b-4c58-bcde-17f823ec4ee1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 02, 2017
Package DI Number
20365702688104
Quantity per Package
6
Contains DI Package
00365702688100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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. | 63 |
| 3 | A medical device with high risk that requires premarket approval | 3 |