Duns Number:063997360
Device Description: LDR Early Result Pregnancy Test 2 ea
Catalog Number
5424296
Brand Name
LEADER
Version/Model Number
5424296
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,K042280,K042280
Product Code
LCX
Product Code Name
KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
Public Device Record Key
107b64da-5574-40c1-b2e0-cca384c7f355
Public Version Date
December 06, 2021
Public Version Number
2
DI Record Publish Date
August 11, 2020
Package DI Number
50096295133917
Quantity per Package
24
Contains DI Package
00096295133912
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |