Duns Number:064608573
Device Description: For in vitro diagnostics use in the detection of human chorionic gonadotropin (hCG) in uri For in vitro diagnostics use in the detection of human chorionic gonadotropin (hCG) in urine using the Clinitek Status® analyzer(qualitative)
Catalog Number
1760
Brand Name
CLINITEST® hCG Pregnancy Test
Version/Model Number
10310618
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
K032563
Product Code
JHI
Product Code Name
Visual, pregnancy hCG, prescription use
Public Device Record Key
e64beb9c-7183-4d76-8bcd-070662837ec4
Public Version Date
August 30, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |