Duns Number:276816717
Device Description: Pre-coated single slides with Poly-L-Lysine to be used to reduce cell loss during wet fixa Pre-coated single slides with Poly-L-Lysine to be used to reduce cell loss during wet fixation and staining (to be used with single sample chambers)
Catalog Number
-
Brand Name
PREVI® COLOR POLY-L-LYSINE SLIDES SINGLE
Version/Model Number
PREVI® COLOR POLY-L-LYSINE SLIDES SINGLE
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
Yes
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
KPA
Product Code Name
Slide stainer, automated
Public Device Record Key
d93ae376-9b42-4aad-aa36-adf79a45990a
Public Version Date
August 24, 2020
Public Version Number
1
DI Record Publish Date
August 14, 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |