Duns Number:227530649
Device Description: A Lipase test system is a device intended for the quantitative in vitro determination of L A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma
Catalog Number
LI3837
Brand Name
LIPASE (LPS)
Version/Model Number
LI3837
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CHI
Product Code Name
Lipase-Esterase, Enzymatic, Photometric, Lipase
Public Device Record Key
a11c3a8c-a71e-4e11-b26b-cfda7948d307
Public Version Date
December 17, 2018
Public Version Number
1
DI Record Publish Date
November 14, 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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |