Duns Number:010655581
Device Description: In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL
Catalog Number
LDL1230
Brand Name
ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol
Version/Model Number
LDL1230
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LBR
Product Code Name
Ldl & Vldl Precipitation, Hdl
Public Device Record Key
b2a975e6-6285-498b-9d10-8eca6935bcb5
Public Version Date
May 12, 2020
Public Version Number
2
DI Record Publish Date
May 18, 2018
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 | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 18 |