FDA.reportPublic FDA data

Thyretain

Primary DI
30014613331490
Brand
Thyretain
Company
DIAGNOSTIC HYBRIDS, INC.
Model
40-1005K.V2
Catalog number
40-1005K.V2
Device description
THYRETAIN CELL & Control SET
Published
2018-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K092229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092229000THYRETAIN TM TSI REPORTER BIOASSAYDiagnostic Hybrids, Inc.2010-05-18JZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613331490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333149030014613331490

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroid stimulating hormone receptor (TSHR), also known as thyrotropin receptor, in a clinical specimen using a chemiluminescent immunoassay method. It is used in the diagnosis of autoimmune thyroid disorders such as hyperthyroidism in Graves’ disease.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1100technicalsupport@quidel.com

Regulatory Flags#

DUNS number
117359612
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
30014613330288D3 Ultra01-010000.V201-010000.V22019-03-07
30014613330875D3 Fastpoint01-12350401-1235042019-03-07
00050428101735CVS Health At Home COVID-19 Test Kit204522895862025-08-08
30014613340089Savanna20382R20382R2024-07-19
30014613339304Savanna20382203822024-04-30
30014613340188CVS Health At Home COVID-19 Test Kit204522895862024-11-20
30014613330240D301-0005001-000502019-04-02
30014613311034LyraM103M1032016-09-15
30014613311157Quidel MolecularM115M1152018-11-16
30014613330752D3 FastpointRespiratory Virus ID Kit01-1200002016-09-15
30014613330769D3 Fastpoint01-120000.B101-120000.B12018-07-22
30014613330776D3 Fastpoint01-120000.B201-120000.B22018-07-22
30014613330813D3 FastpointRSV/MPV ID Kit01-1200022016-09-15
30014613330820D3 Fastpoint01-120002.B101-120002.B12018-07-22
30014613330837D3 Fastpoint01-120002.B201-120002.B22018-07-22
30014613336143SolanaM306M3062018-08-07
30014613338659D301-002007b01-002007b2019-04-23
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30

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
00813545026721MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545026738MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545026745MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545026752MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027148MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027155MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027162MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027179MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
07613336160305Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2020-04-14
07613336160329Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2020-04-14