Duns Number:006999528
Device Description: A convenience kit consisting of 1 Digital Pregnancy Test and 1 Early Result Pregnancy Test A convenience kit consisting of 1 Digital Pregnancy Test and 1 Early Result Pregnancy Test
Catalog Number
-
Brand Name
Kroger
Version/Model Number
Digital & One Step Pregnancy Test
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
K042280,K060128,K042280,K060128
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
cbfa1137-c8e9-42f6-8db0-91a479953ab2
Public Version Date
August 12, 2021
Public Version Number
1
DI Record Publish Date
August 04, 2021
Package DI Number
10041260012508
Quantity per Package
24
Contains DI Package
00041260012501
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |