Duns Number:687910463
Device Description: ADAMII-CD34 Kit is designed for use with the ADAMII instrument, benchtop image-based fluor ADAMII-CD34 Kit is designed for use with the ADAMII instrument, benchtop image-based fluorescence cell counter.ADAMII-CD34 Kit provides the percentages of total and viable cells that are CD34+(%CD34).
Catalog Number
CD34K-050
Brand Name
ADAM
Version/Model Number
ADAMII-CD34 Kit
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
BK180283
Product Code
GKZ
Product Code Name
Counter, Differential Cell
Public Device Record Key
69d13cc8-c8c2-4af5-a341-7bd6032f5752
Public Version Date
November 04, 2020
Public Version Number
2
DI Record Publish Date
September 02, 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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |