FDA.reportPublic FDA data

EliA anti-TG Well

Primary DI
07333066015736
Brand
EliA anti-TG Well
Company
Phadia AB
Model
DECC056420
Catalog number
DECC056420
Device description
EliA anti-TG Well
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K151799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151799000EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB2016-03-25JZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066015057PackageGS14In Commercial Distribution
07333066015736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066015057073330660150577333066015057
07333066015736073330660157367333066015736

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin antibody 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 thyroglobulin in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+469999999999xx@xx.xx

Regulatory Flags#

DUNS number
354019424
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333066014524EliA U1RNP WellDECC055010DECC0550102016-09-23
07333066014562EliA CENP WellDECC055050DECC0550502016-09-23
07333066014623EliA RNP70 WellDECC055110DECC0551102016-09-23
07333066014630EliA GBM WellDECC055140DECC0551402016-09-23
07333066014678EliA Celikey IgG WellDECC055180DECC0551802016-09-23
07333066014715EliA Cardiolipin IgA WellDECC055280DECC0552802016-09-23
07333066014746EliA ß2-Glycoprotein I IgA WellDECC055310DECC0553102016-09-23
07333066014777EliA PR3S WellDECC055360DECC0553602016-09-23
07333066014784EliA MPOS WellDECC055370DECC0553702016-09-23
07333066014791EliA GliadinDP IgA WellDECC055380DECC0553802016-09-23
07333066014807EliA GliadinDP IgG WellDECC055390DECC0553902016-09-23
07333066014814EliA RF IgM WellDECC056000DECC0560002016-09-23
07333066014852EliA M2 WellDECC056490DECC0564902016-09-23
07333066014593EliA Symphony WellDECC055080DECC0550802016-09-23
07333066016115EliA SymphonyS WellDECC056710DECC0567102020-06-30
07333066015798EliA CCP WellDECC066150DECC0661502026-01-29
07333066024202EliA IgG Calibrator WellDECC066090DECC0660902026-01-29
07333066024226EliA Dummy WellDECC066100DECC0661002026-01-29
07333066024240EliA IgA Calibrator WellDECC066160DECC0661602026-01-29
07333066024271EliA IgM Calibrator WellDECC066270DECC0662702026-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336217641Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2026-06-01
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
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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