Duns Number:070371210
Device Description: The Homocysteine Control Kit is intended to be used as an assayed quality control serum wh The Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total Lhomocysteine in human serum or plasma. Size: 6 x 1.5ml
Catalog Number
HOMQ480
Brand Name
MedTest DX Homocysteine Controls
Version/Model Number
HOMQ480
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
LPS
Product Code Name
Urinary Homocystine (Nonquantitative) Test System
Public Device Record Key
3cbff80d-1a5b-40d8-918a-c70db58275d5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 30, 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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |