Duns Number:045361136
Device Description: Stanbio Glycated Serum Protein (GSP) Linearity Set is intended to be used for quality cont Stanbio Glycated Serum Protein (GSP) Linearity Set is intended to be used for quality control procedures in verifying the linearity throughout the reportable range of Stanbio’s Glycated Serum Protein (GSP) LiquiColor®. For in-vitro diagnostic use only.
Catalog Number
2380-201
Brand Name
Glycated Serum Protein Linearity Set
Version/Model Number
2380-201
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 05, 2019
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
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
9c8138e4-7a40-443d-b1ae-f7b39e0c3d25
Public Version Date
April 08, 2019
Public Version Number
3
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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |