Duns Number:005088112
Device Description: Cholesterol Flex® reagent cartridge, 600 tests
Catalog Number
K1027
Brand Name
Dimension Vista® Flex® reagent cartridge CHOL
Version/Model Number
10445143
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
K061655,K061655
Product Code
CHH
Product Code Name
ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
Public Device Record Key
59093a37-fe12-490f-9606-436f5cd6eb60
Public Version Date
November 18, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
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 |