Duns Number:315539452
Device Description: The Leica Autostainer XL (ST5010) is an IVD (in-vitro diagnostics) instrument. The Leica A The Leica Autostainer XL (ST5010) is an IVD (in-vitro diagnostics) instrument. The Leica Autostainer XL (ST5010) is a stainer for la boratory applications and intended for the preparation of histological and cytological tissue samples.
Catalog Number
14045638879
Brand Name
AXL 230-240/50-60 TS5015
Version/Model Number
000000014045638879
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
316449f3-337b-453e-8718-ef4320d07399
Public Version Date
December 17, 2018
Public Version Number
1
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 |