Duns Number:092815364
Device Description: Para-Pak Trichrome Stain is a rapid staining procedure which provides excellent differenti Para-Pak Trichrome Stain is a rapid staining procedure which provides excellent differentiation of internal structures of intestinal parasites as well as facilitating the separation of these organisms from background material and artifacts.
Catalog Number
4001-01
Brand Name
Trichrome Stain
Version/Model Number
4001-01
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
4f457f1b-5bac-490c-8d0a-09fd892df3a9
Public Version Date
July 15, 2021
Public Version Number
1
DI Record Publish Date
July 07, 2021
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 |