Duns Number:051957769
Device Description: A convenience kit consisting of 1 Equate One Step Pregnancy Test, 1 Equate Early Result Pr A convenience kit consisting of 1 Equate One Step Pregnancy Test, 1 Equate Early Result Pregnancy Test and 1 Equate Digital Yes+ No- Pregnancy Test
Catalog Number
-
Brand Name
Equate
Version/Model Number
Triple Test Pregnancy Test Kit
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
df1265b8-01f5-4cec-96ed-84402573ffb9
Public Version Date
November 02, 2018
Public Version Number
1
DI Record Publish Date
October 02, 2018
Package DI Number
10681131240809
Quantity per Package
24
Contains DI Package
00681131240802
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |