FDA.reportPublic FDA data

DIASTAT anti-thyroglobulin

Primary DI
07340058410110
Brand
DIASTAT anti-thyroglobulin
Company
Svar Life Science AB
Model
FATG200
Catalog number
FATG200
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
JZOSystem, Test, Thyroid Autoantibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZOSystem, Test, Thyroid AutoantibodyImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952183000DIASTAT ANTI-THYROGLOBULIN KITShield Diagnostics, Ltd.1995-06-30JZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340058410110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340058410110073400584101107340058410110

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal 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 both thyroglobulin and thyroid peroxidase (anti-TPO; also known as anti-microsomal antibody) 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
Donation ID number
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
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
07613336217641Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2026-06-01
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00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414608754Atellica IM aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414608761Atellica IM aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414609492Atellica IM aTPOII DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414608570ADVIA Centaur aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
00630414608747ADVIA Centaur aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
00630414609409ADVIA Centaur aTPOII DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
15099590763527Access Thyroglobulin Antibody IIBeckman Coulter, Inc.JZO2023-12-01
07613336171479Elecsys Anti-TgRoche Diagnostics GmbHJZO2023-10-31
07613336203521Elecsys Anti-TgRoche Diagnostics GmbHJZO2023-10-31
04048474033694TSH Receptor Autoantibody ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJZO2023-08-29
00840239037084Anti TG Ab ELISADRG International IncJZO2023-08-25
00840239033697TSH Receptor Autoantibody ELISA DRG International IncJZO2023-08-24
00840239035615Anti TPO Ab ELISADRG International IncJZO2023-08-24
B3507204500Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test KitGold Standard Diagnostics CorporationJZO2022-12-03
B3507204600Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test KitGold Standard Diagnostics CorporationJZO2022-12-03
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