Catalog Number

GAHCG-101a

Brand Name

Healgen

Version/Model Number

GAHCG-101a

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

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

af57ba5c-5b7f-486b-8fa4-2448a4f60a88

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 31, 2016

Package DI Number

20816490021128

Quantity per Package

20

Contains DI Package

10816490021121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case