Duns Number:092815364
Device Description: Clearing agent for parasitology, Use as a xylene replacement in Trichrome Stain procedure, Clearing agent for parasitology, Use as a xylene replacement in Trichrome Stain procedure, Ethyl acetate replacement in concentration procedures, Bulk reagent used in EcoStain kit.
Catalog Number
801300
Brand Name
Hemo-De
Version/Model Number
801300
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HYW
Product Code Name
Stain, Trichrome, Mallory'S
Public Device Record Key
9c85871e-33fd-42a4-8dbf-3a6b6a3908c0
Public Version Date
December 17, 2020
Public Version Number
1
DI Record Publish Date
December 09, 2020
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 | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |