Duns Number:317134468
Device Description: The DRG Salivary Estradiol HS ELISA is an enzyme immunoassay for the quantitative in vitro The DRG Salivary Estradiol HS ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free estradiol in saliva.Results may be used to assess fertility problems in women; to diagnose menopause, and to monitor hormone replacement therapy.
Catalog Number
SLV-6145
Brand Name
Salivary Progesterone HS ELISA
Version/Model Number
SLV-6145
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
b5de29ad-53e3-4469-9a58-c98f3f2a5df6
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 |