FDA.reportPublic FDA data

DIASTAT anti-Thyroid Peroxidase

Primary DI
07340058410134
Brand
DIASTAT anti-Thyroid Peroxidase
Company
Svar Life Science AB
Model
FTPO300
Catalog number
FTPO300
Published
2016-08-08
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
K020687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020687000DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300Axis-Shield Diagnostics, Ltd.2002-05-02JZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340058410134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340058410134073400584101347340058410134

GMDN Terms#

Term, Definition table
TermDefinition
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 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

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
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

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Primary DI, Brand, Company table
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00630414608754Atellica IM aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
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