STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KIT - A radioimmunoassay for the semi-quantitative - KRONUS, INC.

Duns Number:181070814

Device Description: A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hyd A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum.

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More Product Details

Catalog Number

KR6015

Brand Name

STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KIT

Version/Model Number

KR6015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121046

Product Code Details

Product Code

PCG

Product Code Name

21-Hydroxylase Antibody (21-Ohab)

Device Record Status

Public Device Record Key

a2a230a3-c914-49d5-93f0-79f29e42dd5d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KRONUS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24