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Panels › Clinical Chemistry › Product code CDP · Class 2

Radioimmunoassay, Total Triiodothyronine

Regulation 862.1710

0510(k)s in 12 months (144 all time)
0recalls in 12 months (20 all time)
13recalls that name a 510(k)
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Top companies in CDP

Company510(k)sRecalls
Abbott Laboratories130
Amersham Corp.70
Beckman Coulter Inc.07
Diagnostic Products Corp.60
Boehringer Mannheim Corp.40
Tosoh Bioscience Inc04
Abbott Ireland Diagnostics Division03
Bd Becton Dickinson Vacutainer Systems Preanalytic30
Bio-Rad Laboratories, Inc.30
E. R. Squibb & Sons, Inc.30
DateFirm and productCodeLinked 510(k)
May 14, 2024QUIDELORTHO
VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589
Open, Classified		 CDPK970016
K994145
Apr 20, 2023Beckman Coulter, Inc.
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
Open, Classified		 CDPNone listed
Jun 2, 2020Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 6
Terminated		 CDPK973966
Jun 2, 2020Beckman Coulter Inc.
Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600
Terminated		 CDPNone listed
Nov 30, 2018Tosoh Bioscience Inc
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specif
Terminated		 CDPK963687
K991252
Oct 12, 2018Abbott Ireland Diagnostics Division
ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free
Terminated		 CDPNone listed
Oct 12, 2018Abbott Ireland Diagnostics Division
ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free
Terminated		 CDPNone listed
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
Terminated		 CDPNone listed
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid
Terminated		 CDPNone listed
Jul 28, 2017Siemens Healthcare Diagnostics, Inc
ADVIA Centaur T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT sys
Terminated		 CDPK041133
May 9, 2017Beckman Coulter Inc.
Access Total T3, A34435H, Catalog No. 33830
Terminated		 CDPK973966
Jun 30, 2016Beckman Coulter Inc.
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human seru
Terminated		 CDPNone listed
Oct 7, 2015Beckman Coulter Inc.
Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human se
Terminated		 CDPK960913
Jun 4, 2015ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales
Terminated		 CDPK964310
Dec 3, 2014Abbott Ireland Diagnostics Division
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% so
Terminated		 CDPK983439
Jan 30, 2014Siemens Healthcare Diagnostics
T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMU
Terminated		 CDPK974634
Jan 30, 2014Siemens Healthcare Diagnostics
T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 5
Terminated		 CDPK974634
Aug 20, 2012Beckman Coulter Inc.
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function
Terminated		 CDPK940833
K955435 +1
Apr 20, 2006Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than
Terminated		 CDPK964310
Feb 23, 2006Tosoh Bioscience Inc
TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantitative measurement of Total Triiodothyronine Human Serum. Each box of product contains 5 trays of 20 te
Terminated		 CDPK936229

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