Duns Number:070371210
Device Description: Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calibration of Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calibration of Lipoprotein(a).1 x 20 ml, 1 x 10 ml
Catalog Number
LPA400
Brand Name
MedTest DX, Inc. Lipoprotein (a)
Version/Model Number
LPA400
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
K011568
Product Code
JIS
Product Code Name
Calibrator, Primary
Public Device Record Key
02c5d5b1-2ef9-473f-beca-9081235407ec
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 |