Duns Number:070371210
Device Description: auto HDL/LDL Calibrator, For the calibration of autoHDL™ and autoLDL™ Cholesterol Reagent auto HDL/LDL Calibrator, For the calibration of autoHDL™ and autoLDL™ Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only. Size: 3 x 40mL, 3 x 14mL
Catalog Number
HDLC480
Brand Name
MedTest DX auto HDL/LDL Calibrator
Version/Model Number
HDLC480
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
K992002
Product Code
LBR
Product Code Name
Ldl & Vldl Precipitation, Hdl
Public Device Record Key
5b2a2263-4f3f-449c-a155-303539fabfc5
Public Version Date
March 08, 2022
Public Version Number
4
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 |