Duns Number:080243910
Device Description: The DoublecheQ Pregnancy Test is designed to be used for a qualitative determination of el The DoublecheQ Pregnancy Test is designed to be used for a qualitative determination of elevated human chorionic gonadotropin in urine. The result can be read visually in minutes to indicate a positive or negative result for pregnancy.
Catalog Number
100-13
Brand Name
DoublecheQ Pregnancy Test
Version/Model Number
Cassette
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
0f38e7c8-f976-4e02-b3e0-4adfdc7b8024
Public Version Date
August 09, 2019
Public Version Number
3
DI Record Publish Date
June 03, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |