Duns Number:687910463
Device Description: ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). This syste ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in human specimen.
Catalog Number
ADAM-rWBC
Brand Name
ADAM
Version/Model Number
ADAM-rWBC
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
BK120015,BK120068
Product Code
GKZ
Product Code Name
Counter, Differential Cell
Public Device Record Key
f646ecba-d06d-4196-8f6d-bcc3ec84e27f
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 30, 2016
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 |