Duns Number:483609579
Device Description: A convenience kit consisting of 1 Rite Aid Pharmacy Digital Pregnancy Test and 1 Rite Aid A convenience kit consisting of 1 Rite Aid Pharmacy Digital Pregnancy Test and 1 Rite Aid Pharmacy Early Result Pregnancy Test
Catalog Number
-
Brand Name
Rite Aid Pharmacy
Version/Model Number
Family Planning Pregnancy Tests Digital & Early Result
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 22, 2019
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
8e739eee-c88c-41b9-9c4f-88eed0093f9c
Public Version Date
July 23, 2019
Public Version Number
4
DI Record Publish Date
February 26, 2018
Package DI Number
10011822037249
Quantity per Package
24
Contains DI Package
00011822037242
Package Discontinue Date
July 22, 2019
Package Status
Not 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |