Catalog Number

-

Brand Name

INSTANT-VIEW FSH Midstream Cassette Test, 2t

Version/Model Number

02-2560-2

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CGJ

Product Code Name

Radioimmunoassay, Follicle-Stimulating Hormone

Public Device Record Key

a1a09bd5-06dd-41e6-b3f9-6738d6a201ad

Public Version Date

May 02, 2019

Public Version Number

2

DI Record Publish Date

October 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-