Duns Number:429572365
Device Description: Lipase NG OC CTRL 2 must be used only to verify the performance of the Lipase NG.Use the C Lipase NG OC CTRL 2 must be used only to verify the performance of the Lipase NG.Use the Control Material like the specimens, according to the indicated analytical procedure.
Catalog Number
04Y85-11
Brand Name
Lipase NG OC CTRL 2
Version/Model Number
04Y85-11
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
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
828f844c-0d2d-432d-9f02-1fc50659e2c4
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 |