Duns Number:075150847
Device Description: The hCG ELISA is intended for the quantitative determination of human chorionic gonadotrop The hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting.
Catalog Number
EIA-1783
Brand Name
Human Chorionic Gonadotropin (hCG) ELISA
Version/Model Number
EIA-1783
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K991741
Product Code
JHI
Product Code Name
Visual, pregnancy hCG, prescription use
Public Device Record Key
915ac122-b410-438a-8310-7020b7c065be
Public Version Date
August 30, 2022
Public Version Number
3
DI Record Publish Date
March 20, 2019
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |