Duns Number:429572365
Device Description: ACE Liquid reagent is for use in the determination of Angiotensin converting enzyme (ACE) ACE Liquid reagent is for use in the determination of Angiotensin converting enzyme (ACE) activity in human serum or plasma.For In Vitro Diagnostic use.
Catalog Number
1767001
Brand Name
ACE Liquid
Version/Model Number
1767001
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
-
Product Code
KQN
Product Code Name
Radioassay, Angiotensin Converting Enzyme
Public Device Record Key
d23658f2-b274-4164-9f31-5427d91869b6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 29, 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |