Duns Number:388240673
Device Description: Quantitative determination of IgA in human CSF and paired CSF/serum on BN Systems
Catalog Number
OQAI15
Brand Name
N Latex IgA
Version/Model Number
10873689
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
K024038
Product Code
CZP
Product Code Name
IGA, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
0705734f-6b53-4898-8bba-adc84e745364
Public Version Date
November 18, 2021
Public Version Number
3
DI Record Publish Date
June 23, 2020
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 |