Duns Number:317134468
Device Description: The DRG:Hybrid-XL Estradiol is an enzyme immunoassay for the quantitative in vitro diagnos The DRG:Hybrid-XL Estradiol is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Estradiol in serum and plasma.
Catalog Number
HYE-5349
Brand Name
Estradiol
Version/Model Number
HYE-5349
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
CHP
Product Code Name
RADIOIMMUNOASSAY, ESTRADIOL
Public Device Record Key
30bfeece-1a6a-43ac-ac0b-6ce47fe67c95
Public Version Date
June 15, 2021
Public Version Number
1
DI Record Publish Date
June 07, 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 |