Pregnenolone ELISA - For the direct quantitative determination of - DRG International Inc

Duns Number:075150847

Device Description: For the direct quantitative determination of Pregnenolone by an enzyme immunoassay in huma For the direct quantitative determination of Pregnenolone by an enzyme immunoassay in human serum.

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More Product Details

Catalog Number

EIA-4912

Brand Name

Pregnenolone ELISA

Version/Model Number

EIA-4912

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

-

Product Code Details

Product Code

JNG

Product Code Name

RADIOIMMUNOASSAY, PREGNENOLONE

Device Record Status

Public Device Record Key

1642cf7d-96b7-47c2-8f7c-c2d01bd3eb84

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