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Aeskulisa® Ss-A

FDA UDI

Class II (US FDA UDI)

by Aesku.Diagnostics GmbH & Co. KG

Identity

Trade Name
AESKULISA® SS-A FDA UDI
Generic Name
SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of highly purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies are species-specific (directed against human protein only) and preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). FDA UDI
Model / Reference
3107 FDA UDI
Description
AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of highly purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies are species-specific (directed against human protein only) and preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). FDA UDI

Identifiers

Primary DI / UDI-DI
04250289500494 FDA UDI
FDA Product Code
LJM FDA UDI
GMDN Term
SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)

Aeskulisa® Ss-A by Aesku.Diagnostics GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aesku.Diagnostics GmbH & Co. KG

Sources (1)

  • FDA UDI 6a48537f-7482-4273-818b-c1b8926ba145 34 fields · synced Jun 1, 2026