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AESKULISA® ANA-8Pro

FDA UDI

Class II (US FDA UDI)

by Aesku.Diagnostics GmbH & Co. KG

Identity

Trade Name
AESKULISA® ANA-8Pro FDA UDI
Generic Name
Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. FDA UDI
Model / Reference
7101US FDA UDI
Description
AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. FDA UDI

Identifiers

Catalog Number
7101US FDA UDI
Primary DI / UDI-DI
04250289502917 FDA UDI
510(k) Number
K032469 FDA UDI
FDA Product Code
LJM FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening 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 antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

AESKULISA® ANA-8Pro by Aesku.Diagnostics GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple antinuclear antibody (ANA) screening 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 49886db0-99b4-4033-be4c-983c34d9e4a1 36 fields · synced Jun 8, 2026