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Aeskulisa® U1-70

FDA UDI

Class II (US FDA UDI)

by Aesku.Diagnostics GmbH & Co. KG

Identity

Trade Name
AESKULISA® U1-70 FDA UDI
Generic Name
U1-RNP antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is a tool in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE). FDA UDI
Model / Reference
3104 FDA UDI
Description
AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is a tool in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE). FDA UDI

Identifiers

Primary DI / UDI-DI
04250289500463 FDA UDI
510(k) Number
K032469 FDA UDI
FDA Product Code
LJM FDA UDI
GMDN Term
U1-RNP 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: U1-RNP antibody IVD, kit, enzyme immunoassay (EIA)

Aeskulisa® U1-70 by Aesku.Diagnostics GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as U1-RNP antibody IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K032469 also covers:

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 742a0acf-095b-4aac-80ba-b02a7b30ef1f 35 fields · synced Jun 8, 2026