Duns Number:064608573
Device Description: 4 wedges per reagent , 2 reagent, 1100 test per carton
Catalog Number
10729780
Brand Name
ADVIA Chemistry Creatine Kinase
Version/Model Number
10729780
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
-
Product Code
CGS
Product Code Name
NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES
Public Device Record Key
e6b78b94-26b3-45b5-b4c4-25a4c0e5b232
Public Version Date
November 18, 2021
Public Version Number
4
DI Record Publish Date
November 12, 2018
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 |