Duns Number:084963177
Device Description: Artisan Alpha Amylase
Catalog Number
-
Brand Name
Artisan Alpha Amylase
Version/Model Number
AR171
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 31, 2023
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LIJ
Product Code Name
PEROXIDASE ANTI-PEROXIDASE IMMUNOHISTOCHEMICAL STAIN
Public Device Record Key
177545e8-78f2-4fa2-997f-bcae1398a73d
Public Version Date
July 20, 2022
Public Version Number
3
DI Record Publish Date
September 17, 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 | 1076 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| 3 | A medical device with high risk that requires premarket approval | 8 |