Duns Number:315539452
Device Description: The HistoCore SPECTRA CV is a fully automated coverslipper that is used to apply mounting The HistoCore SPECTRA CV is a fully automated coverslipper that is used to apply mounting media between the slide and coverglass. Then a coverglass is applied in order to preserve conserve the specimen and to create a uniform visual surface for microscopic research on histological and cytological tissue samples for medical diagnostics (e.g. cancer diagnostics). This instrument may be operated only in conjunction with the coverglasses and mounting media approved by Leica.
Catalog Number
14051454200
Brand Name
HistoCore SPECTRA CV
Version/Model Number
000000014051454200
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
6466cf24-8cff-405e-b275-0edae94e3399
Public Version Date
August 20, 2020
Public Version Number
2
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 |