Catalog Number

W1-C

Brand Name

QuickProfile™ HCG Test Card

Version/Model Number

W1-C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

18d6b1cf-fa0c-441b-9423-2384126b9d83

Public Version Date

October 21, 2019

Public Version Number

1

DI Record Publish Date

October 11, 2019

Package DI Number

M901W1C1

Quantity per Package

25

Contains DI Package

M901W1C0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK