Duns Number:690430688
Device Description: ASFA Spotter : Bio samples such as cells, drugs and viruses can be dispensed on well plate ASFA Spotter : Bio samples such as cells, drugs and viruses can be dispensed on well plates or microchips with high accuracy and precision.
Catalog Number
-
Brand Name
ASFA SPOTTER
Version/Model Number
MBD-MA-ST
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
JTC
Product Code Name
Device, Microtiter Diluting/Dispensing
Public Device Record Key
8202608d-ece7-4442-86cd-b2d0c8928a2c
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 |