FDA.reportPublic FDA data

Anti-ds-DNA-G ELISA

Primary DI
B24235DSGHUE010
Brand
Anti-ds-DNA-G ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
35-DSGHU-E01
Catalog number
35-DSGHU-E01
Device description
Anti-ds-DNA-G ELISA is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. Anti-dsDNA antibodies mainly recognize the phosphat units of the DNA, thus these autoantibodies also bind single stranded DNA (ssDNA). To ensure correct quantitation of anti-dsDNA antibodies the used antigen has been proven to be free of contamination with ssDNA. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE).
Published
2017-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSWAnti-Dna Antibody, Antigen And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSWAnti-Dna Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041628000AESKULISA DS DNA GAesku Diagnostics2004-10-14LSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B24235DSGHUE010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Double stranded DNA antibody (anti-dsDNA) 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 double stranded DNA (anti-dsDNA) 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

Contacts#

Phone, Email table
PhoneEmail
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250289513401AESKUSLIDES® nDNA (Crithidia luciliae)Aesku.Diagnostics GmbH & Co. KGLSW2024-11-15
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LSW2023-12-14
00894175000237AccuDiag ™Diagnostic Automation, Inc.LSW2021-08-06
07333066019406EliA dsDNA WellPhadia ABLSW2019-03-06
07333066010557EliA dsDNA WellPhadia ABLSW2019-03-06
04250289510394AESKUSLIDES nDNA (Crithidia luciliae)Aesku.Diagnostics GmbH & Co. KGLSW2018-05-14
04250289503037AESKULISA® dsDNA-GAesku.Diagnostics GmbH & Co. KGLSW2017-03-17
04250289503440AESKULISA® dsDNA GAesku.Diagnostics GmbH & Co. KGLSW2017-02-28
04250289500647AESKULISA® dsDNA-GAesku.Diagnostics GmbH & Co. KGLSW2016-09-27
08426950624646QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.LSW2016-08-31
08426950627760QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.LSW2016-08-31