Duns Number:315539452
Device Description: The Leica Small Linear Stainer ST4020 is used for the automated preparation of routine his The Leica Small Linear Stainer ST4020 is used for the automated preparation of routine histo¬logical and cytological stains. It is i ntended for use in pathology laboratories to assist with the following tasks: • Staining thin tissue sections or cytological specimens on slides. Frozen sections can also be stained. • The instrument may be operated only ccording to the instructions contained in this manual.
Catalog Number
14050954854
Brand Name
Leica ST4020 China
Version/Model Number
000000014050954854
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
KPA
Product Code Name
Slide stainer, automated
Public Device Record Key
c113f26a-3bb8-44bc-a5bc-5a4ee3724ee6
Public Version Date
January 04, 2019
Public Version Number
1
DI Record Publish Date
December 04, 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 |