Duns Number:229062427
Device Description: The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality cont The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma.
Catalog Number
FHCY200
Brand Name
Axis-Shield Homocysteine Controls
Version/Model Number
FHCY200
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
K980907
Product Code
DFC
Product Code Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Public Device Record Key
4f971af8-835d-4596-b55a-faba4cd1e822
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 01, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |