FDA.reportPublic FDA data

ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin

Primary DI
07333066003993
Brand
ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin
Company
Phadia AB
Model
14-4507-01
Catalog number
14-4507-01
Device description
ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin
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
JNLIMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNLImmunochemical, Thyroglobulin AutoantibodyImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072661000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072661000IMMUNOCAP THYRLOBULIN IMMUNOCAPPhadia US, Inc.2007-11-20JNL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066004006PackageGS13In Commercial Distribution
07333066003993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066004006073330660040067333066004006
07333066003993073330660039937333066003993

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin 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 thyroglobulin in a clinical specimen, using an enzyme immunoassay (EIA) 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
04048474041149Anti-Thyroid Peroxidase (Anti-TPO) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJNL2023-08-31
00840239041142Anti-Thyroid Peroxidase (Anti-TPO) ELISADRG International IncJNL2019-03-20
00816870020396Anti-TPO AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JNL2019-02-11
00816870022079Monobind AccuLite Anti-TPO CLIA Kit - 96 WellsMONOBIND, INC.JNL2019-02-11
00816879020045Autostat II Anti-Thyroid Peroxidase HYCOR BIOMEDICAL LLCJNL2016-09-26
00613745030203ImmunoWELL TPO IgG Quantitative TestGenBioJNL2016-09-24
00613745030302ImmunoWELL Thyroglobulin IgG Quantitative TestGenBioJNL2016-09-24
00613745039121ImmunoDOT Thyroid Positive ControlGenBioJNL2016-09-24
00613745058252ImmunoDOT Thyroid Autoimmunity PanelGenBioJNL2016-09-24
00613745058894ImmunoDOT Thyroid Autoimmunity PanelGenBioJNL2016-09-24
07333066004006ImmunoCAP Specific IgG, Antigen tg, ThyroglobulinPhadia ABJNL2016-09-23
05391516743808Trinity BiotechCLARK LABORATORIES, INC.JNL2016-09-22
15099590202910Access Thyroglobulin Antibody IIBeckman Coulter, Inc.JNL2016-09-09