Duns Number:069146876
Device Description: Camco Wright Stain solution for automated and manual staining of blood smears for hematolo Camco Wright Stain solution for automated and manual staining of blood smears for hematological studies.
Catalog Number
400
Brand Name
Camco
Version/Model Number
400
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KQC
Product Code Name
Stains, Hematology
Public Device Record Key
62c32ccd-6b89-44b5-bace-c7f5a0ccff68
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 10, 2017
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |