Duns Number:690430688
Device Description: ASFA Scanner : Fluorescence scanner for cell analysis used for general cell-based biochemi ASFA Scanner : Fluorescence scanner for cell analysis used for general cell-based biochemical analysis.
Catalog Number
-
Brand Name
ASFA SCANNER
Version/Model Number
MBD-SC4C-S
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
KHO
Product Code Name
Fluorometer, For Clinical Use
Public Device Record Key
6be46319-027e-4bde-9346-d4f2e2115481
Public Version Date
February 06, 2020
Public Version Number
1
DI Record Publish Date
January 29, 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 | 2 |