Duns Number:383120136
Device Description: TDHisto/Cyto is a software used for managing medical information in the field of laborat TDHisto/Cyto is a software used for managing medical information in the field of laboratories performing histology, non-gynecological and gynecological cytology and autopsy activities..
Catalog Number
-
Brand Name
TDHisto/Cyto
Version/Model Number
TDHisto/Cyto
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JQP
Product Code Name
Calculator/Data Processing Module, For Clinical Use
Public Device Record Key
098b1fde-1161-4743-acda-3dbbfec08cd0
Public Version Date
August 16, 2022
Public Version Number
1
DI Record Publish Date
August 08, 2022
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 | 4 |