Duns Number:227530649
Device Description: A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro dete A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine.
Catalog Number
AY3855
Brand Name
P AMY
Version/Model Number
AY3855
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
Yes
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
K971825
Product Code
JFJ
Product Code Name
Catalytic Methods, Amylase
Public Device Record Key
8a7dc279-badb-4237-a3f5-b242cc63be38
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 09, 2016
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |