Duns Number:690571724
Catalog Number
-
Brand Name
AIA-PACK HGH Sample Diluting Solution
Version/Model Number
N/A
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
-
Product Code
CFL
Product Code Name
Radioimmunoassay, Human Growth Hormone
Public Device Record Key
e08e0d47-e3dc-4b5b-ab3a-47148efd5660
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
July 24, 2019
Package DI Number
14560189211435
Quantity per Package
6
Contains DI Package
04560189211438
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 40 |
2 | A medical device with a moderate to high risk that requires special controls. | 95 |