Duns Number:159655021
Device Description: e.p.t.® Analog 2 Ct
Catalog Number
-
Brand Name
e.p.t. Early Pregnancy Test
Version/Model Number
EPT visual
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
K040329,K040329,K040329
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
27005db1-2d61-47a1-9032-8028f3f3821d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
10363736952027
Quantity per Package
12
Contains DI Package
00363736952020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping case