Duns Number:429572365
Device Description: Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnost Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use.
Catalog Number
04Y85-01
Brand Name
Lipase NG OC Cal
Version/Model Number
04Y85-01
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
-
Product Code
JIT
Product Code Name
Calibrator, Secondary
Public Device Record Key
bc01996a-853c-484c-8e7a-dfb4c70e7900
Public Version Date
April 24, 2019
Public Version Number
1
DI Record Publish Date
April 16, 2019
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 |