AESKUSLIDES ANCA Formalin - AESKUSLIDES® ANCA is an indirect - Aesku.Diagnostics GmbH & Co. KG

Duns Number:341714388

Device Description: AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granu AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

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More Product Details

Catalog Number

-

Brand Name

AESKUSLIDES ANCA Formalin

Version/Model Number

54.051.US

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172461

Product Code Details

Product Code

MOB

Product Code Name

Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

Device Record Status

Public Device Record Key

1828a10e-94b3-4df1-8d1d-c80148ad3bbe

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 25, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AESKU.DIAGNOSTICS GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 77