FDA.reportPublic FDA data

Free Triiodothyronine (FT3) ELISA

Primary DI
04049016139232
Brand
Free Triiodothyronine (FT3) ELISA
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EQ 1016-9601
Published
2022-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CDPRadioimmunoassay, Total Triiodothyronine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDPRadioimmunoassay, Total TriiodothyronineClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016139232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016139232040490161392324049016139232

GMDN Terms#

Term, Definition table
TermDefinition
Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of free triiodothyronine (FT3) 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
322209263
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EI 2610-9601-2 G2026-05-29
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026446AccuDiag™ T3 ELISA KitDiagnostic Automation, Inc.CDP2026-03-02
14562185395447CL AIA-PACK T3 TEST CUPTOSOH CORPORATIONCDP2025-09-01
24562185395444CL AIA-PACK T3 TEST CUPTOSOH CORPORATIONCDP2025-09-01
00840239023858Free Triiodothyronine (fT3) ELISADRG International IncCDP2024-09-23
00840239038012Free T3 ELISADRG International IncCDP2024-09-23
00840239053565T3 freeDRG International IncCDP2024-09-23
04048474023855Free Triiodothyronine (fT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
04048474038019Free T3 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
04048474053562T3 freeDRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
00840239056979T-3DRG International IncCDP2024-08-13
04048474056976T-3DRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-08-13
B24220TT3HUE011Total Triiodothyronine (Total T3) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CDP2024-07-22
04048474052756Total Triiodothyronine (tT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-09-01
04048474052770Free Triiodothyronine (fT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-09-01
04048474041071Free Triiodothyronine (fT3) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-31
04048474045697T3 Total ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-31
04048474017809Triiodothyronine (T3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-29
00840239045690T3 Total ELISA DRG International IncCDP2023-08-25
00840239052759Total Triiodothyronine (tT3) ELISADRG International IncCDP2023-08-25
15099590201661Access Free T3Beckman Coulter, Inc.CDP2023-06-26
15099590227210Access Total T3Beckman Coulter, Inc.CDP2023-06-26
00894175000886AccuDiag ™Diagnostic Automation, Inc.CDP2023-06-14
00850049545976QmedixDiagnostic Automation, Inc.CDP2023-06-13
10758750033782VITROSORTHO CLINICAL DIAGNOSTICSCDP2023-03-28
06925912718505iFlash-T3Shenzhen YHLO Biotech Co., Ltd.CDP2022-10-26
07613336171578Elecsys FT3 IIIRoche Diagnostics GmbHCDP2021-10-02
07613336171585Elecsys FT3 IIIRoche Diagnostics GmbHCDP2021-10-02
07613336171646Elecsys T3Roche Diagnostics GmbHCDP2021-08-13
07613336171653Elecsys T3Roche Diagnostics GmbHCDP2021-08-13
00840239017802Triiodothyronine (T3) ELISADRG International IncCDP2021-06-07