FDA.reportPublic FDA data

nDNA Test Kit

Primary DI
10862534000331
Brand
nDNA Test Kit
Company
ANTIBODIES INCORPORATED
Model
15-211
Catalog number
15-211
Device description
Anti-nDNA Antibody Test Kit
Published
2016-12-20
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
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K812314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K812314000CRITHIDNA ANTI-DNA TEST KITAntibodies, Inc.1981-09-01DHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10862534000331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086253400033110862534000331

GMDN Terms#

Term, Definition table
TermDefinition
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen, using a fluorescent immunoassay method.

Regulatory Flags#

DUNS number
048944128
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
10862534000300ANA Test Kit 15-11215-1122016-12-20
10862534000317ANA Test Kit 15-11315-1132016-12-20
10862534000324ANA Test Kit 15-12315-1232016-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04250289513487AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
04250289513562AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLDHN2024-11-08
G5229023441ANA/HEp-2 IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023451ANA/HEp-2 IgG IFA 180 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023601ANA/HEp-2 IgG IFA 600 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023701ANA/HEp-2 IgG IFA 1200 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023901ANA/HEp-2 IgG IFA 120 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229024201Anti-nDNA IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
08059304340109dIFine Automated Microscope VISIA LAB SRLDHN2022-09-07
00813545026561MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
00813545026578MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
00813545026905MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
00813545026912MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
04260186125096HELIOSAesku.Systems GmbH & Co. KGDHN2020-03-02
00845714002045Immco Diagnostics, IncIMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714002052Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714002069Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714004100Immco Diagnostics Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714004117Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
04049016135722IFA 40: HEp-20-10 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGDHN2018-05-17
04049016135739IFA 40: HEp-20-10 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGDHN2018-05-17
04250289503020AESKULISA® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-03-02
04250289503501AESKULISA® ANA HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
04250289504461AESKUSLIDES® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
04250289504935AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
10862534000300ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000317ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000324ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20