Duns Number:064608573
Device Description: Myoglobin - ADVIA Chem. - RGT - 2x100 tests
Catalog Number
4862455
Brand Name
ADVIA® Chemistry MYO Myoglobin Reagents
Version/Model Number
10361939
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 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
K122599
Product Code
DDR
Product Code Name
MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
b71f8257-0b17-476b-84ab-b660f9b0fa83
Public Version Date
August 04, 2022
Public Version Number
6
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 |