Duns Number:045623154
Device Description: Amylase Reagent, for the quantitative kinetic determination of a-amylase activity in human Amylase Reagent, for the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only. Size: 1 x 1L, 1 x 200mL
Catalog Number
HA965-1200
Brand Name
Pointe Scientific, Inc. Amylase
Version/Model Number
HA965-1200
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
K023396
Product Code
CIJ
Product Code Name
Saccharogenic, Amylase
Public Device Record Key
822f6bc7-69eb-4784-8953-5e9159437cf8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |