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AESKUSLIDES® ANA HEp-2-Gamma

FDA UDI

Class II (US FDA UDI)

by Aesku.Diagnostics GmbH & Co. KG

Identity

Trade Name
AESKUSLIDES® ANA HEp-2-Gamma FDA UDI
Generic Name
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay FDA UDI
Device Name
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum by manual microscopy or with the HELIOS® Automated IFA System. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings. FDA UDI
Model / Reference
51.101.US.Bulk5 FDA UDI
Description
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum by manual microscopy or with the HELIOS® Automated IFA System. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings. FDA UDI

Identifiers

Catalog Number
51.101.US.Bulk5 FDA UDI
Primary DI / UDI-DI
04250289504942 FDA UDI
510(k) Number
K153117 FDA UDI
FDA Product Code
DHN FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay 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

Yes

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, fluorescent immunoassay

AESKUSLIDES® ANA HEp-2-Gamma 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, fluorescent immunoassay.

Cleared under the same submission

K153117 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 b3a9dc3d-41d1-471e-a9fa-14bd3d5e1979 36 fields · synced Jun 8, 2026