RHEUMATOID FACTOR IgA - Rheumatoid Factor IgA is an ELISA test system for - ORGENTEC Diagnostika GmbH

Duns Number:328133103

Device Description: Rheumatoid Factor IgA is an ELISA test system for the quantitative measurement of IgA clas Rheumatoid Factor IgA is an ELISA test system for the quantitative measurement of IgA class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.

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More Product Details

Catalog Number

ORG522A

Brand Name

RHEUMATOID FACTOR IgA

Version/Model Number

ORG522A

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

DHR

Product Code Name

System, Test, Rheumatoid Factor

Device Record Status

Public Device Record Key

a632b0e1-b10c-4aeb-be2b-6f75d89d9f56

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORGENTEC DIAGNOSTIKA GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21