Duns Number:540156544
Device Description: Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprot Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (hAFP)
Catalog Number
B079-201
Brand Name
AutoDELFIA hAFP Kit
Version/Model Number
B079-201
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 04, 2020
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
P970037,P970037,P970037,P970037
Product Code
LOK
Product Code Name
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
Public Device Record Key
274039f8-e811-4900-85c7-1fb653256ce3
Public Version Date
November 25, 2020
Public Version Number
5
DI Record Publish Date
September 24, 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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| 3 | A medical device with high risk that requires premarket approval | 2 |