Duns Number:102855447
Device Description: The CytoLayer Slide Treatment Solution is intended to be used to treat the Hydrophylic Plu The CytoLayer Slide Treatment Solution is intended to be used to treat the Hydrophylic Plus Slides prior to sedimentation of liquid cytology samples. This treatment significantly improves adherence of cells to the slide surface and is critical for reliable processing of liquid cytology samples.
Catalog Number
BSB 4032
Brand Name
CytoLayer Slide treatment Solution
Version/Model Number
1000 ml
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
e99db65c-4ffa-418b-806e-652bf5c1cfe8
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 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 | 3887 |