Duns Number:315539452
Device Description: The Leica CV5030 is a robotic coverslipper for coverslipping tissue sections, cells or swa The Leica CV5030 is a robotic coverslipper for coverslipping tissue sections, cells or swabs mounted on specimen slides with cover slips made out of glass using a wide variety of differ¬ent cover slip mountants. It may only be used with instrument accessories approved by Leica Biosystems Nussloch GmbH.
Catalog Number
149CVTS5025
Brand Name
Leica CV5030-TS5025
Version/Model Number
149CVTS5025
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KIM
Product Code Name
DEVICE FOR SEALING MICROSECTIONS
Public Device Record Key
282f9676-1261-4b84-8683-a40cb5e517f7
Public Version Date
August 20, 2020
Public Version Number
2
DI Record Publish Date
November 16, 2018
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 | 97 |