Duns Number:227530649
Device Description: The product is intended for the quantitative in vitro determination of IgA in serum or pla The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
Catalog Number
IA3895
Brand Name
IgA
Version/Model Number
IA3895
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2016
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
K955794
Product Code
CZP
Product Code Name
Iga, Antigen, Antiserum, Control
Public Device Record Key
fdcb1ee6-5b3e-45b1-9c68-abf1902d2a2e
Public Version Date
July 06, 2018
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |