Catalog Number

-

Brand Name

INSTANT-VIEW Pregnancy Urine Dip-Strip Test

Version/Model Number

02-2487-25

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)

-

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

412a853c-4809-47f7-a930-1a8b43f54ebb

Public Version Date

May 01, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-