Duns Number:388240673
Device Description: N Protein Standard SL is a multi-analyte calibrator for the establishment of reference cur N Protein Standard SL is a multi-analyte calibrator for the establishment of reference curves on the Siemens Systems
Catalog Number
OQIM13
Brand Name
N Protein Standard SL
Version/Model Number
10446073
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K052788,K052788
Product Code
JIX
Product Code Name
CALIBRATOR, MULTI-ANALYTE MIXTURE
Public Device Record Key
117da6e6-f66c-43e1-a4bb-ed5742ea95be
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
September 24, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |