Duns Number:010717890
Device Description: The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth.
Catalog Number
1452-31
Brand Name
Dropper Spinal Fluid Control Level 2 Set 3x3mL
Version/Model Number
1452-31
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
K831527
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
b609f57f-ae51-43f1-a09e-3b635733b54e
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
September 26, 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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |