Catalog Number

25000058

Brand Name

FastPack® IP Testo Kit (90)

Version/Model Number

Testo Immunoassay

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101388,K101388

Product Code

CDZ

Product Code Name

Radioimmunoassay, Testosterones And Dihydrotestosterone

Public Device Record Key

449fee43-badc-4668-b285-2203061c1724

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-