Duns Number:215865786
Device Description: VITROS Immunodiagnostic Products CK-MB Reagent Pack
Catalog Number
6199336
Brand Name
VITROS
Version/Model Number
6199336
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212648
Product Code
JHX
Product Code Name
FLUOROMETRIC METHOD, CPK OR ISOENZYMES
Public Device Record Key
a498cb3a-4fe1-4f01-9b0d-75a4e88c76e2
Public Version Date
November 01, 2022
Public Version Number
1
DI Record Publish Date
October 24, 2022
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 | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 17 |