Catalog Number

STP-10-0

Brand Name

STATTEST Home Pregnancy Test

Version/Model Number

STP-10-0

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JHI

Product Code Name

Visual, Pregnancy Hcg, Prescription Use

Public Device Record Key

13640463-d1d9-4172-bdb3-74d4f10f319e

Public Version Date

June 26, 2020

Public Version Number

1

DI Record Publish Date

June 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-