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AESKULISA® Jo-1

FDA UDI

Class II (US FDA UDI)

by Aesku.Diagnostics GmbH & Co. KG

Identity

Trade Name
AESKULISA® Jo-1 FDA UDI
Generic Name
Multiple myositis-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyltRNA-synthetase (HRS) for the quantitative and qualitative detection of antibodies against Jo-1 (named after the prototype patient) in human serum. Human sera with anti-Jo-1 antibodies solely recognize HRS of higher eukaryotes and react with highest affinity with the human enzyme. The assay is a tool in the diagnosis of polymyositis and dermatomyositis. FDA UDI
Model / Reference
3113 FDA UDI
Description
AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyltRNA-synthetase (HRS) for the quantitative and qualitative detection of antibodies against Jo-1 (named after the prototype patient) in human serum. Human sera with anti-Jo-1 antibodies solely recognize HRS of higher eukaryotes and react with highest affinity with the human enzyme. The assay is a tool in the diagnosis of polymyositis and dermatomyositis. FDA UDI

Identifiers

Primary DI / UDI-DI
04250289500555 FDA UDI
510(k) Number
K032469 FDA UDI
FDA Product Code
LJM FDA UDI
GMDN Term
Multiple myositis-associated 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: Multiple myositis-associated antibody IVD, kit, enzyme immunoassay (EIA)

AESKULISA® Jo-1 by Aesku.Diagnostics GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple myositis-associated 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 de5211fe-968c-4620-8a8a-38e294aa216b 35 fields · synced Jun 8, 2026