ANTI-CARDIOLIPIN IgA - Anti-Cardiolipin Screen is an ELISA test system - ORGENTEC Diagnostika GmbH

Duns Number:328133103

Device Description: Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgA cl Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.

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More Product Details

Catalog Number

ORG515A

Brand Name

ANTI-CARDIOLIPIN IgA

Version/Model Number

ORG515A

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

K962469

Product Code Details

Product Code

MID

Product Code Name

System, Test, Anticardiolipin Immunological

Device Record Status

Public Device Record Key

eea281c8-1550-4a61-8cc8-a1a2b9df8fe4

Public Version Date

July 06, 2018

Public Version Number

3

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