Duns Number:317134468
Device Description: Enzyme immunoassay for the in-vitro diagnostic quantitative determination of Serotonin in Enzyme immunoassay for the in-vitro diagnostic quantitative determination of Serotonin in human serum, plasma, platelets and urine.
Catalog Number
EIA-1300
Brand Name
Serotonin ELISA
Version/Model Number
EIA-1300
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
CDA
Product Code Name
ACID, NITROUS AND NITROSONAPHTHOL, 5-HYDROXYINDOLE ACETIC ACID/SEROTONIN
Public Device Record Key
ba84ede6-ab7e-446a-bffb-f798d6c75d7e
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 |