Duns Number:315539452
Device Description: The HistoCore SPECTRA ST is an in-vitro diagnostics instrument. The HistoCore SPECTRA ST i The HistoCore SPECTRA ST is an in-vitro diagnostics instrument. The HistoCore SPECTRA ST is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
Catalog Number
14051254354
Brand Name
HistoCore SPECTRA ST
Version/Model Number
000000014051254354
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
03b7e5e6-c5a7-4de2-bdef-504a960d50d2
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 |