Duns Number:429572365
Device Description: The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprotein (AGP) The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprotein (AGP) in serum and plasma by immunoturbidimetry. For In Vitro Diagnostic Use only.
Catalog Number
A26838
Brand Name
alpha 1-Acid Glycoprotein
Version/Model Number
A26838
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
LKL
Product Code Name
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Public Device Record Key
cccbfe42-8328-4d2f-bdcc-9d63a37eeec7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 15, 2017
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 |