Duns Number:008171162
Device Description: Strip Description: For the in vitro quantitative determination of amylase concentration i Strip Description: For the in vitro quantitative determination of amylase concentration in human plasma from whole blood samples.
Catalog Number
-
Brand Name
SPOTCHEM™ II Amylase
Version/Model Number
77113
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050652,K050652
Product Code
CIJ
Product Code Name
SACCHAROGENIC, AMYLASE
Public Device Record Key
ac7739f9-124a-494c-90ff-6f912a52def9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |