Catalog Number

-

Brand Name

HealthyWiser

Version/Model Number

HCG Test Strip

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

-

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

344c8f9a-522e-4495-acb2-6ce0338021a8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 31, 2016

Package DI Number

16970429840147

Quantity per Package

50

Contains DI Package

06970429840140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-