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)
Top companies in CHP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01 Open, Classified |
CHP | K955647 |
| Mar 3, 2022 | Siemens 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 |
CHP | None listed |
| Mar 3, 2022 | Siemens 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 |
CHP | None listed |
| Mar 3, 2022 | Siemens 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 |
CHP | None listed |
| Mar 3, 2022 | Siemens 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 |
CHP | None listed |
| Mar 3, 2022 | Siemens 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 |
CHP | None listed |
| Mar 3, 2022 | Siemens 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 |
CHP | None listed |
| Sep 22, 2021 | bioMerieux, Inc. VIDAS Estradiol II, REF 30431-01 Open, Classified |
CHP | None listed |
| Feb 24, 2020 | Siemens 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 |
CHP | None listed |
| Feb 24, 2020 | Siemens 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 |
CHP | None listed |
| Feb 5, 2019 | Abbott 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 |
CHP | None listed |
| Feb 5, 2019 | Abbott 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 |
CHP | None listed |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i Estradiol Reagent Kit, List Number 07P5020 Terminated |
CHP | None listed |
| Mar 21, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista MULTI 1 SDIL, KD693, SMN# 10469971 Terminated |
CHP | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK hsE2; Part Number: 025225
Assay, Reproductive Hormone Terminated |
CHP | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Estradiol; Part Number: 025274
Assay, Reproductive Hormone Terminated |
CHP | None listed |
| Jun 7, 2017 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack.
Siemens Material Number (SMN): 10379810, 10379811, 10697756. Terminated |
CHP | K100293 |
| May 5, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Estradiol (E2) Flex reagent cartridge Terminated |
CHP | None listed |
| Mar 20, 2017 | BioMerieux 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 |
CHP | K955647 |
| Jul 14, 2016 | ORTHO-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 |
CHP | K970643 |
| Jul 13, 2016 | Diasorin 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 |
CHP | None listed |
| Mar 24, 2016 | Abbott Laboratories The ARCHITECT Estradiol Kit
Intended to measure estradiol, an estrogenic steroid, in plasma. Terminated |
CHP | None listed |
| Mar 7, 2016 | Roche 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 |
CHP | None listed |
| Mar 7, 2016 | Roche 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 |
CHP | None listed |
| Jan 13, 2016 | Siemens 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 |
CHP | K932926 |
| Jan 13, 2016 | Siemens 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 |
CHP | K932926 |
| Jan 13, 2016 | Siemens 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 |
CHP | None listed |
| Jan 13, 2016 | Siemens 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 |
CHP | None listed |
| Nov 23, 2010 | Beckman 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 |
CHP | K973743 |
| Apr 7, 2007 | Abbott 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 |
CHP | None listed |
| May 29, 2003 | Beckman Coulter Inc ACCESS Estradiol Reagent Test System Terminated |
CHP | K973743 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.