Duns Number:079264306
Device Description: SEEKER™ Quality Control Dried Blood Spot KitContains 5 levels: QC Base Pool, QC Low, QC In SEEKER™ Quality Control Dried Blood Spot KitContains 5 levels: QC Base Pool, QC Low, QC Intermediate, QC Medium, and QC High
Catalog Number
3416
Brand Name
SEEKER™
Version/Model Number
3416
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
DEN150035
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
5adb588e-85d5-4cc4-94d2-986785847bf0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 18, 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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |