Duns Number:429572365
Device Description: Lipase NG Cal must be used only for the calibration of Lipase NG kinetic colorimetric dire Lipase NG Cal must be used only for the calibration of Lipase NG kinetic colorimetric direct determination.For In Vitro Diagnostic use only.
Catalog Number
B83544
Brand Name
Lipase NG Cal
Version/Model Number
B83544
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
K033501
Product Code
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
a85afddc-ff90-43f1-a30f-8c5215de44ea
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 07, 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |