Duns Number:092815364
Device Description: Trichrome Blue is a stain which provides excellent differentiation of microsporidium spore Trichrome Blue is a stain which provides excellent differentiation of microsporidium spores in fresh and preserved stool, urine sediment, nasopharyngeal aspirates and other bodily fluids.
Catalog Number
400501
Brand Name
Trichrome Blue Stain
Version/Model Number
400501
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
JTS
Product Code Name
Stains, Microbiologic
Public Device Record Key
081d7e60-a87f-437c-95a4-0a75caf83111
Public Version Date
November 03, 2020
Public Version Number
1
DI Record Publish Date
October 26, 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 |