FDA.reportPublic FDA data

DIASTAT anti-Jo-1

Primary DI
07340058410479
Brand
DIASTAT anti-Jo-1
Company
Svar Life Science AB
Model
FAJO200
Catalog number
FAJO200
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
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
K912292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912292000DIASTAT ANTI-JO-1 KITShield Diagnostics, Ltd.1991-07-30DHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340058410479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340058410479073400584104797340058410479

GMDN Terms#

Term, Definition table
TermDefinition
Jo-1 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 anti-Jo-1 antibodies 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
07340058410035DIASTAT anti-dsDNAFDNA100FDNA1002016-08-12
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
10862534000331nDNA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000300ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000317ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20