Duns Number:005088112
Device Description: Chemistry 1 Calibrator, 6 (3A x 2.3 mL; 3B x 2.3 mL)
Catalog Number
KC110B
Brand Name
Dimension Vista® CHEM 1 CAL
Version/Model Number
10716281
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 03, 2022
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
K140790
Product Code
JIX
Product Code Name
CALIBRATOR, MULTI-ANALYTE MIXTURE
Public Device Record Key
c61d77ba-7baf-4c18-97ed-8fc486081c05
Public Version Date
March 04, 2022
Public Version Number
7
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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |