Duns Number:859323297
Device Description: Liquid Human Spinal Fluid Control Level 1/Level 2, 2 ml. Contains 3 vials Level 1 and 3 vi Liquid Human Spinal Fluid Control Level 1/Level 2, 2 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.
Catalog Number
323-26-12
Brand Name
NA
Version/Model Number
323-26-12
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
DFI
Product Code Name
Total Spinal-Fluid, Antigen, Antiserum, Control
Public Device Record Key
df866d5b-92b9-4ed0-b952-f5fee36bdad6
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
March 29, 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 | 19 |