Duns Number:008254708
Device Description: The Access AFP Sample Diluent is intended for use with the Access AFP assay to dilute pati The Access AFP Sample Diluent is intended for use with the Access AFP assay to dilute patient samples containing AFP concentrations greater than the S6 calibrator.
Catalog Number
33216
Brand Name
Access AFP Sample Diluent
Version/Model Number
33216
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
LOK
Product Code Name
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
Public Device Record Key
dc3d5f0f-be24-4611-a363-87fcf6ec55c1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2014
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 | 319 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 503 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 1 |