Duns Number:227530649
Device Description: An α-amylase test system is a device intended for the quantitative in vitro determination An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.
Catalog Number
AY3805
Brand Name
AMY
Version/Model Number
AY3805
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
K953211
Product Code
CIJ
Product Code Name
Saccharogenic, Amylase
Public Device Record Key
26dc299d-fe09-4767-8027-f00c630c3952
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 |