Duns Number:317134468
Device Description: The DRG IGF-1 600 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic The DRG IGF-1 600 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin-like Growth Factor 1, IGF-1, in serum.
Catalog Number
EIA-4140
Brand Name
IGF-1 600 ELISA
Version/Model Number
EIA-4140
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)
Yes
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
d6fc157c-2331-43c2-be63-742687a3f27e
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
June 11, 2021
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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |