Duns Number:388240673
Device Description: Quantitative determination of myoglobin in human serum and plasma on BN Systems
Catalog Number
OWIA17
Brand Name
N Latex Myoglobin
Version/Model Number
10873690
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
K902154
Product Code
DDR
Product Code Name
MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
795f7618-254a-47de-9e01-abb6407e3a53
Public Version Date
November 18, 2021
Public Version Number
3
DI Record Publish Date
May 29, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |