FDA.reportPublic FDA data

AESKULISA® U1-70

Primary DI
04250289502948
Brand
AESKULISA® U1-70
Company
Aesku.Diagnostics GmbH & Co. KG
Model
7104US
Catalog number
7104US
Device 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).
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032469000AESKULISA ANA 8PROAesku, Inc.2003-12-16LLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250289502948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289502948042502895029484250289502948

GMDN Terms#

Term, Definition table
TermDefinition
U1-RNP antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to U1-RNP antigen (anti-U1-RNP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341714388
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250289503440AESKULISA® dsDNA G30-7142US30-7142US2017-02-28
04250289503501AESKULISA® ANA HEp-2 30-7115US30-7115US2017-02-28
04250289504942AESKUSLIDES® ANA HEp-2-Gamma51.101.US.Bulk551.101.US.Bulk52025-05-27
04250289513487AESKUSLIDES® ANA-HEp-2 gamma 51.181.US51.181.US2025-04-06
04250289513562AESKUSLIDES® ANA-HEp-2 gamma 51.181.US.BULK551.181.US.BULK52025-04-06
04250289500005AESKUSLIDES® ANA-HEp-2 51.1002016-09-27
04250289500425AESKULISA® ANA-8Pro 31012016-09-27
04250289500449AESKULISA® ENA-6S 31022016-09-27
04250289500456AESKULISA® ENA-6Pro 31032016-09-27
04250289500579AESKULISA® ANA-HEp-2 31152016-09-27
04250289502917AESKULISA® ANA-8Pro 7101US7101US2017-02-28
04250289502924AESKULISA® ENA-6S 7102US7102US2017-02-28
04250289502931AESKULISA® ENA-6Pro 7103US7103US2017-02-28
04250289503020AESKULISA® ANA-HEp-2 7115US7115US2017-03-02
04250289504461AESKUSLIDES® ANA-HEp-2 51.100.US51.100.US2017-02-28
04250289504935AESKUSLIDES® ANA-HEp-2 gamma 51.101.US51.101.US2017-02-28
04250289510387AESKUSLIDES ANCA Formalin54.051.US2018-05-25
04250289510394AESKUSLIDES nDNA (Crithidia luciliae)53.100.US2018-05-14
04250289513531HELMED® Automated IFA ProcessorREF.HEL-1000.USREF.HEL-1000.US2025-01-03
04260186120008HELIOS® Automated IFA SystemREF.IOS-1000.USREF.IOS-1000.US2025-01-03

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04048474027846Sm IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
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