Beckman Coulter Inc.
158 FDA actions
Access Total T4 Calibrator, Catalog No. 33805
Beckman Coulter, Inc.
MicroScan Neg MIC 3J REF C54814
Beckman Coulter, Inc.
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan
Beckman Coulter, Inc.
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining ant
Beckman Coulter, Inc.
Access BNP II
Beckman Coulter, Inc.
Access anti-HBc IgM
Beckman Coulter, Inc.
Access anti-HBc Total
Beckman Coulter, Inc.
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjun
Beckman Coulter, Inc.
CellMek SPS Sample Preparation System, REF: C44603, with software
Beckman Coulter, Inc.
Access anti-HAV IgM
Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratio
Beckman Coulter, Inc.
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for us
Beckman Coulter Inc.
Access Rubella IgG
Beckman Coulter, Inc.
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Beckman Coulter, Inc.
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Beckman Coulter, Inc.
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Beckman Coulter Inc.
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Beckman Coulter, Inc.
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i
Beckman Coulter, Inc.
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Beckman Coulter Inc.
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part
Beckman Coulter Inc.
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Beckman Coulter Inc.
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Beckman Coulter Inc.
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Beckman Coulter Inc.
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Beckman Coulter Inc.
iQ200 Series
Beckman Coulter, Inc.
Access anti-HAV
Beckman Coulter, Inc.
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Beckman Coulter, Inc.
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
Beckman Coulter, Inc.
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
Beckman Coulter, Inc.
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Beckman Coulter Inc.
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Beckman Coulter, Inc.
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Beckman Coulter, Inc.
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Beckman Coulter, Inc.
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Beckman Coulter, Inc.
Access hsTnI
Beckman Coulter, Inc.
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pl
Beckman Coulter Inc.
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Beckman Coulter, Inc.
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
Beckman Coulter, Inc.
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C4
Beckman Coulter Inc.
DxI 9000 Access Immunoassay Analyzer C11137
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Beckman Coulter, Inc.
Access hsTnI
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Beckman Coulter, Inc.
Access Testosterone assay, Catalog Number 33560
Beckman Coulter, Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065.
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065
Beckman Coulter Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, se
Beckman Coulter, Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065
Beckman Coulter Inc.
Access Toxo IgG
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Beckman Coulter, Inc.
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Beckman Coulter, Inc.
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney,
Beckman Coulter, Inc.
Access Cortisol; DxC 500i Clinical Analyzer
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Beckman Coulter, Inc.
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Beckman Coulter Inc.
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int
Beckman Coulter, Inc.
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac t
Beckman Coulter, Inc.
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determi
Beckman Coulter Inc.
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination o
Beckman Coulter, Inc.
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The
Beckman Coulter, Inc.
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMM
Beckman Coulter Inc.
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic
Beckman Coulter, Inc.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdinatio
Beckman Coulter, Inc.
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitati
Beckman Coulter, Inc.
Access Toxo IgM II
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137;
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,
Beckman Coulter, Inc.
Access Syphilis
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter, Inc.
Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter, Inc.
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Beckman Coulter Inc.
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It
Beckman Coulter, Inc.
UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniC
Beckman Coulter, Inc.
Access Thyroglobulin Antibody II
Beckman Coulter, Inc.
Access Thyroglobulin
Beckman Coulter, Inc.
Access Thyroglobulin
Beckman Coulter, Inc.
Access OV Monitor
Beckman Coulter, Inc.
Access BR Monitor
Beckman Coulter, Inc.
Access Intrinsic Factor Ab
Beckman Coulter, Inc.
Access EPO
Beckman Coulter, Inc.
Access NT-proBNP
Beckman Coulter, Inc.
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Beckman Coulter, Inc.
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Beckman Coulter, Inc.
Access Ferritin
Beckman Coulter, Inc.
Access Free T4
Beckman Coulter, Inc.
Access Intact PTH
Beckman Coulter, Inc.
Access CK-MB
Beckman Coulter, Inc.
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
Beckman Coulter, Inc.
Access SHBG
Beckman Coulter, Inc.
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e)
Beckman Coulter, Inc.
iQ Waste Well Adapter, Part Number: 700-3393
Beckman Coulter, Inc.
REV 2 Flowcell Capsule Spare, Part Number: C04154
Beckman Coulter, Inc.
Access hsTnI
Beckman Coulter, Inc.
Access hsTnI
Beckman Coulter, Inc.
DxFLEX Flow Cytometer; ClearLLab 10C Panels
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Beckman Coulter, Inc.
Access Thyroglobulin Calibrators
Beckman Coulter, Inc.
Access Thyroglobulin Antibody II
Beckman Coulter, Inc.
Access Myoglobin
Beckman Coulter, Inc.
Access Thyroglobulin
Beckman Coulter, Inc.
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Beckman Coulter Inc.
Access Folate Assay
Beckman Coulter, Inc.
Ringed DxI Reaction Vessels (RVs)
Beckman Coulter, Inc.
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Beckman Coulter, Inc.
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Beckman Coulter, Inc.
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbe
Beckman Coulter, Inc.
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Beckman Coulter, Inc.
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
Beckman Coulter Inc.
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
Beckman Coulter, Inc.
Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
Beckman Coulter Inc.
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
Beckman Coulter, Inc.
Access PCT
Beckman Coulter, Inc.
MicroScan Prompt Inoculation System-D
Beckman Coulter, Inc.
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbishe
Beckman Coulter, Inc.
Access Cortisol
Beckman Coulter, Inc.
Access AMH
Beckman Coulter, Inc.
Access 25(OH) Vitamin D Total
Beckman Coulter, Inc.
Access Testosterone
Beckman Coulter, Inc.
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Beckman Coulter, Inc.
Access Total ßhCG (5th IS)
Beckman Coulter, Inc.
Access Vitamin B12
Beckman Coulter, Inc.
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Beckman Coulter, Inc.
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
Beckman Coulter, Inc.
MicroScan WalkAway-40 plus Instrument REF B1018-283
Beckman Coulter Inc.
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
Beckman Coulter Inc.
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
Beckman Coulter Inc.
MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
Beckman Coulter Inc.
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
Beckman Coulter Inc.
MicroScan WalkAway-96 plus Instrument REF B1018-284
Beckman Coulter Inc.
Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Contro
Beckman Coulter, Inc.
Total Immunoglobulin E (IgE)
Beckman Coulter, Inc.
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Beckman Coulter Inc.
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Beckman Coulter Inc.
Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Beckman Coulter Inc.
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Beckman Coulter Inc.
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UD
Beckman Coulter Inc.
Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1
Beckman Coulter Inc.
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces betwe
Beckman Coulter Inc.
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI:
Beckman Coulter Inc.
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743
Beckman Coulter Inc.
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Beckman Coulter Inc.
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C1
Beckman Coulter, Inc.
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01
Beckman Coulter Inc.