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Panels › Clinical Chemistry › Product code CHP · Class 1

Radioimmunoassay, Estradiol

Regulation 862.1260

0510(k)s in 12 months (50 all time)
0recalls in 12 months (31 all time)
8recalls that name a 510(k)
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Top companies in CHP

DateFirm and productCodeLinked 510(k)
Jan 4, 2023Biomerieux Inc
VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
Open, Classified
CHPK955647
Mar 3, 2022Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
Open, Classified
CHPNone listed
Mar 3, 2022Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Open, Classified
CHPNone listed
Mar 3, 2022Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
Open, Classified
CHPNone listed
Mar 3, 2022Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Open, Classified
CHPNone listed
Mar 3, 2022Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
Open, Classified
CHPNone listed
Mar 3, 2022Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Open, Classified
CHPNone listed
Sep 22, 2021bioMerieux, Inc.
VIDAS Estradiol II, REF 30431-01
Open, Classified
CHPNone listed
Feb 24, 2020Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the
Terminated
CHPNone listed
Feb 24, 2020Siemens Healthcare Diagnostics, Inc.
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradi
Terminated
CHPNone listed
Feb 5, 2019Abbott Ireland Diagnostics Division
Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in ser
Terminated
CHPNone listed
Feb 5, 2019Abbott Ireland Diagnostics Division
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human se
Terminated
CHPNone listed
Nov 21, 2018Abbott Ireland Diagnostics Division
Alinity i Estradiol Reagent Kit, List Number 07P5020
Terminated
CHPNone listed
Mar 21, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista MULTI 1 SDIL, KD693, SMN# 10469971
Terminated
CHPNone listed
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
Terminated
CHPNone listed
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone
Terminated
CHPNone listed
Jun 7, 2017Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Terminated
CHPK100293
May 5, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Vista Estradiol (E2) Flex reagent cartridge
Terminated
CHPNone listed
Mar 20, 2017BioMerieux SA
VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantit
Terminated
CHPK955647
Jul 14, 2016ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF3
Terminated
CHPK970643
Jul 13, 2016Diasorin Inc.
LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human seru
Terminated
CHPNone listed
Mar 24, 2016Abbott Laboratories
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Terminated
CHPNone listed
Mar 7, 2016Roche Diagnostics Operations, Inc.
Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/mL; R1 Biotinylated polyclonal anti-estr
Terminated
CHPNone listed
Mar 7, 2016Roche Diagnostics Operations, Inc.
Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estr
Terminated
CHPNone listed
Jan 13, 2016Siemens Healthcare Diagnostics, Inc
IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE2000 syst
Terminated
CHPK932926
Jan 13, 2016Siemens Healthcare Diagnostics, Inc
IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers
Terminated
CHPK932926
Jan 13, 2016Siemens Healthcare Diagnostics, Inc
Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human seru
Terminated
CHPNone listed
Jan 13, 2016Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human s
Terminated
CHPNone listed
Nov 23, 2010Beckman Coulter Inc.
Access Immunoassay Systems Estradiol, Part Number: 33540 Intended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradi
Terminated
CHPK973743
Apr 7, 2007Abbott Laboratories
ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 10
Terminated
CHPNone listed
May 29, 2003Beckman Coulter Inc
ACCESS Estradiol Reagent Test System
Terminated
CHPK973743

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