Free Testosterone ELISA - For the direct quantitative determination of Free - DRG International Inc

Duns Number:075150847

Device Description: For the direct quantitative determination of Free Testosterone by enzyme immunoassay in hu For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum. For in vitro diagnostic use only.

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


More Product Details

Catalog Number

EIA-4638

Brand Name

Free Testosterone ELISA

Version/Model Number

EIA-4638

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K030730

Product Code Details

Product Code

CDZ

Product Code Name

RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Device Record Status

Public Device Record Key

b9f3e0fc-ba79-4302-8a62-295657709c3a

Public Version Date

June 15, 2021

Public Version Number

1

DI Record Publish Date

June 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRG INTERNATIONAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 32