AESKULISA® SS-B - AESKULISA SS-B is a solid phase enzyme - Aesku.Diagnostics GmbH & Co. KG

Duns Number:341714388

Device Description: AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ SS-B for the quantitative and qualitative detection of antibodies against Laantigen / SS-B in human serum. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE).

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More Product Details

Catalog Number

7110US

Brand Name

AESKULISA® SS-B

Version/Model Number

7110US

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

K032469

Product Code Details

Product Code

LJM

Product Code Name

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Device Record Status

Public Device Record Key

8a1c9cb5-7790-4939-ab1a-fbe25e176dcc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 28, 2017

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