Healgen - hCG women pregnancy Test midstream (Urine; - Healgen Scientific Limited Liability Company

Duns Number:031802328

Device Description: hCG women pregnancy Test midstream (Urine; 25mIU/ml)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

GAHCG-103a

Brand Name

Healgen

Version/Model Number

GAHCG-103a

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Device Record Status

Public Device Record Key

a7069a62-a06f-438c-91c0-32d69c3de9be

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 31, 2016

Additional Identifiers

Package DI Number

20816490021135

Quantity per Package

50

Contains DI Package

10816490021138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"HEALGEN SCIENTIFIC LIMITED LIABILITY COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 240