Duns Number:429572365
Device Description: The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination of the l The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.
Catalog Number
17401B
Brand Name
Lipase Color Liquid
Version/Model Number
17401B
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
K961179
Product Code
CHI
Product Code Name
Lipase-Esterase, Enzymatic, Photometric, Lipase
Public Device Record Key
e952378d-9a0d-4725-8813-bb4bb4350579
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 16, 2017
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 |