Catalog Number

-

Brand Name

FERTILITY HCG IM KIT

Version/Model Number

77777888804

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PQD

Product Code Name

Blood Specimen Collection Convenience Kit (Excludes Hiv)

Public Device Record Key

001fba18-2098-4ba3-979d-7a8146af6a2e

Public Version Date

February 01, 2022

Public Version Number

1

DI Record Publish Date

January 24, 2022

Package DI Number

M752777778888045

Quantity per Package

100

Contains DI Package

M752777778888040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box