AESKULISA® Glia-A - AESKULISA Glia-A is a solid phase enzyme - Aesku.Diagnostics GmbH & Co. KG

Duns Number:341714388

Device Description: AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified alphaGliadi AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgA antibodies against gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy).

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More Product Details

Catalog Number

-

Brand Name

AESKULISA® Glia-A

Version/Model Number

3501

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K052439

Product Code Details

Product Code

MST

Product Code Name

Antibodies, Gliadin

Device Record Status

Public Device Record Key

4e22f96e-9622-43e9-8153-574a3fc8aa73

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2016

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