Duns Number:171857493
Device Description: The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chor The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum.
Catalog Number
BC-1027
Brand Name
BioCheck hCG EIA Test Kit
Version/Model Number
BC-1027
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)
-
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
e01d8b61-9210-4b9b-a870-2a9ef3c9dd2d
Public Version Date
October 16, 2019
Public Version Number
1
DI Record Publish Date
October 08, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |