FDA.reportPublic FDA data

DIASTAT anti-dsDNA

Primary DI
07340058410035
Brand
DIASTAT anti-dsDNA
Company
Svar Life Science AB
Model
FDNA100
Catalog number
FDNA100
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KTLAnti-Dna Indirect Immunofluorescent Solid Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTLAnti-Dna Indirect Immunofluorescent Solid PhaseImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905386000DISTAT ANTI-DSDNA KITShield Diagnostics, Ltd.1990-12-13KTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340058410035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340058410035073400584100357340058410035

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
559894501
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
07340058410004DIASTAT anti-Ro (SS-A)FARO300FARO3002016-08-12
07340058410011DIASTAT anti-La (SS-B)FALA200FALA2002016-08-12
07340058410028DIASTAT anti-Sm/RNPFRNP200FRNP2002016-08-12
07340058410059DIASTST anti-SmFASM200FASM2002016-08-12
07340058410110DIASTAT anti-thyroglobulinFATG200FATG2002016-08-12
07340058410134DIASTAT anti-Thyroid PeroxidaseFTPO300FTPO3002016-08-08
07340058410141DIASTAT anti-B2 Glycoprotein-1 IgGFBGP200FBGP2002016-08-12
07340058410158DIASTAT anti-B2-Glycoprotein-1 IgMFBGP100FBGP1002016-08-12
07340058410196DIASTAT anti-Cardiolipin IgGFCAR100GFCAR100G2016-08-12
07340058410233DIASTAT anti-Cardiolipin IgMFCAR100MFCAR100M2016-08-12
07340058410400DIASTAT total anti-CardiolipinFCAR100TFCAR100T2016-08-12
07340058410417DIASTAT anti-MitochondrialFMIT200FMIT2002016-08-12
07340058410431CCPointCCPoint20USCCPoint20US2016-09-09
07340058410462DIASTAT anti-SCL-70FSCL200FSCL2002016-08-12
07340058410479DIASTAT anti-Jo-1FAJO200FAJO2002016-08-12
07340058410486DIASTAT ANAFANA200FANA2002016-08-12
07340058410493DIASTAT ENA Single Well ScreenFSWS200FSWS2002016-08-12
07340058410509DIASTAT ENA ProfileFAID200FAID2002016-08-12
07340058410615EDIA anti-CCPFCCP100FCCP1002016-08-12
07340058410639WIESLAB ANCA Screen kitCP111CP1112016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059304340222dIFine DNA ClassifierVISIA LAB SRLKTL2024-11-08
04049016137894IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGKTL2024-09-11
04049016152989IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGKTL2023-07-05
08426951056538NOVA Lite® DAPI dsDNA Crithidia Luciliae KitINOVA DIAGNOSTICS, INC.KTL2021-03-31
04049016107057IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGKTL2020-08-28
04049016107026IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGKTL2018-04-26
04049016107033IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGKTL2018-04-26
04049016107064IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGKTL2018-04-26
04049016107149IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGKTL2018-04-26
04049016107156IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGKTL2018-04-26
04049016107187IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGKTL2018-04-26
00813545025335DNA(C.lucilae) 500 Test(L) SCIMEDX CORPORATIONKTL2016-09-20
00813545023096DNA(C. luciliae) 50 Test(L) SCIMEDX CORPORATIONKTL2016-09-19
00813545023119DNA(C. luciliae) 100 Test(L) SCIMEDX CORPORATIONKTL2016-09-19
00813545020682DNA 5 Well Slide PackSCIMEDX CORPORATIONKTL2016-09-16
00813545020705DNA 10 Well Slide SCIMEDX CORPORATIONKTL2016-09-16
00847817016240KallestadBIO-RAD LABORATORIES, INC.KTL2016-09-12