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FDA-Registered Company Profile for BECKMAN COULTER, INC.
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FDA-Supplied Establishment Information: |
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Establishment Registration Number: |
2122870 |
Company Name: |
BECKMAN COULTER, INC. |
Address: |
1000 LAKE HAZELTINE DR. |
Address 2: |
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City: |
CHASKA |
State |
MN |
Zip / Postal Code: |
55318-1084 |
County: |
CARVER |
Country: |
US |
Establishment Operation Code(s): |
AA - Initial Distributor
MM - Manufacturer
MR - Remanufacturer
MS - Specification Developer
RR - Repackager/Relabeller
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Establishment Status Code: |
A -
Active
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Year of Most Recent Initial or Annual Registration: |
2007 |
FDA-Supplied Owner/Operator Information: |
Owner/Operator Number: |
2050012 |
Company Name: |
BECKMAN COULTER, INC.
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Address: |
4300 N. HARBOR BLVD. |
Address 2: |
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City: |
FULLERTON |
State: |
CA |
Zip / Postal Code: |
92835 |
Country: |
US |
Owner/Operator Phone: |
714-871-4848
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FDA-Supplied Official Correspondent Information: |
Official Correspondent Name: |
MS. REGINA O'MEARA |
Company Name: |
BECKMAN COULTER, INC. |
Address: |
200 SOUTH KRAEMER BLVD. |
Address 2: |
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City: |
BREA |
State: |
CA |
Zip / Postal Code: |
92821 |
Country: |
US |
Official Corespondent Phone Number: |
714-993-5321 8383
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Other Establishment Information: |
Establishment Phone: |
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Fax: |
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General Email: |
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Web Site: |
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Company Brochure: |
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Keywords: |
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Company Description: |
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Services Offered: |
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About Us: |
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Differentiation: |
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FDA-Registered Products Offered by BECKMAN COULTER, INC.
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Common Device Name |
Proprietary Device Name |
1 |
ACCESS TOXO IGM II |
ACCESS TOXO IGM II REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
2 |
AFP ENZYME IMMUNOASSAY (EIA) |
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
3 |
AFP ENZYME IMMUNOASSAY (EIA) |
ACCESS AFP REAGENTS |
4 |
ALBUMIN FLUORESCEIN CONJUGATED ANTISERA |
ALBUMIN FLUORESCEIN CONJUGATED ANTISERA |
5 |
ALBUMIN SINGLE RADIAL IMMUNODIFFUSION KIT |
QUANTIPLATE ALBUMIN SINGLE RADIAL IMMUNODIFFUSION KIT |
6 |
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) |
LSA 290 ALPHA-1-ACID GLYCOPROTEIN ASSAY |
7 |
ALPHA-1-ANTITRYPSIN SINGLE RADIAL IMMUNODIFFUSION KIT |
QUANTIPLATE OR ENDOPLATE TM ALPHA-1-ANTITRYPSIN SINGLE RADIA |
8 |
ANTI-THYROID PEROXIDASE ANTIBODY TEST |
ACCESS TPO ANTIBODY AND ACCESS TPO ANTIBODY CALS |
9 |
BURRO ANTISERA TO HUMAN LAMBDA LIGHT CHAIN |
BURRO ANTISERA TO HUMAN LAMBDA LIGHT CHAIN |
10 |
BURRO, GOAT OR RABBIT ANTISERA TO HUMAN KAPPA LIGHT CHAIN |
BURRO, GOAT OR RABBIT ANTISERA TO HUMAN KAPPA LIGHT CHAIN |
11 |
CALIBRATOR |
ULTRASENSITIVE HGH CALIBRATORS ON THE ACCESS (R) IMMUNOASSAY SYSTEM |
12 |
CEA ENZYME IMMUNOASSAY |
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
13 |
CK-MB ENZYME IMMUNOASSAY |
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS |
14 |
CORTISOL EIA |
ACCESS CORTISOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
15 |
CORTISOL EIA (ENZYME IMMUNOASSAY) |
ACCESS CORTISOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
16 |
DEHYDROEPIANDROSTERONE (FREE AND SULFATE) TEST SYSTEM |
ACCESS DHEA-S REAGENT ACCESS DHEA-S CALIBRATORS |
17 |
DIGOXIN EIA |
ACCESS DIGOXIN REAGENTS ON THE ACCESS IMMUOASSAY ANALYZER |
18 |
DOUBLE DIFFUSION PLATES |
OUCHTERLONY DOUBLE DIFFUSION KIT |
19 |
ENZYME IMMUNOASSAY TO MEASURE IGM ANTIBODIES TO RUBELL |
ACCESS RUBELLA IGM |
20 |
EXTRADIOL EIA (ENZYME IMMUNOASSAY) |
ACCESS ESTRAIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
21 |
FERRITIN EIA |
ACCESS FERRITIN REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
22 |
FIBRINOGEN FLUORESCEIN CONJUGATED ANTISERA |
FIBRINOGEN FLUORESCEIN CONJUGATED ANTISERA |
23 |
FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY |
ACCESS D-DIMER REAGENT |
24 |
FOLATE EIA (ENZYME IMMUNOASSAY) |
ACCESS FOLATE REAGENTS ON THE ACCESS IMUNOASSAY ANALYZER |
25 |
FREE T3 (ENZYME IMMUNOASSAY) |
ACCESS FREE T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
26 |
FREE T4 EIA |
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
27 |
GAMMA GLOBULIN, FLUORESCEIN CONJUGATED ANTISERA |
GAMMA GLOBULIN, FLUORESCEIN CONJUGATED ANTISERA |
28 |
GOAT ANTI-TOTAL IMMUNOGLOBULINS |
FLUORESCEIN CONJUGATED F(AB')2 FRACTION GOAT ANTISERUM TO TO |
29 |
GOAT ANTISERA TO HUMAN ALPHA-2-MACROGLOBULIN |
GOAT ANTISERA TO HUMAN ALPHA-2-MACROGLOBULIN |
30 |
GOAT ANTISERA TO HUMAN ALPHA-FETOPROTEIN |
GOAT ANTISERA TO HUMAN ALPHA-FETOPROTEIN |
31 |
GOAT ANTISERA TO HUMAN BETA-2-MICROGLOBULIN |
GOAT ANTISERA TO HUMAN BETA-2-MICROGLOBULIN |
32 |
GOAT ANTISERA TO HUMAN BETA-LIPOPROTEIN |
GOAT ANTISERA TO HUMAN BETA-LIPOPROTEIN |
33 |
GOAT ANTISERA TO HUMAN C-REACTIVE PROTEIN |
GOAT ANTISERA TO HUMAN C-REACTIVE PROTEIN |
34 |
GOAT ANTISERA TO HUMAN C1Q |
GOAT ANTISERA TO HUMAN C1Q |
35 |
GOAT ANTISERA TO HUMAN CERULOPLASMIN |
GOAT ANTISERA TO HUMAN CERULOPLASMIN |
36 |
GOAT ANTISERA TO HUMAN COMPLEMENT C1S |
GOAT ANTISERA TO HUMAN COMPLEMENT C1S |
37 |
GOAT ANTISERA TO HUMAN FIBRINOGEN |
GOAT ANTISERA TO HUMAN FIBRINOGEN |
38 |
GOAT ANTISERA TO HUMAN PLASMINOGEN |
GOAT ANTISERA TO HUMAN PLASMINOGEN |
39 |
GOAT OR RABBIT ANTISERA TO HUMAN GAMMA GLOBULINS |
GOAT OR RABBIT ANTISERA TO HUMAN GAMMA GLOBULINS |
40 |
GOAT OR RABBIT ANTISERA TO HUMAN IGG (GAMMA CHAIN SPECIFIC) |
GOAT OR RABBIT ANTISERA TO HUMAN IGG (GAMMA CHAIN SPECIFIC) |
41 |
GOAT OR RABBIT ANTISERA TO HUMAN IGM (MU CHAIN SPECIFIC) |
GOAT OR RABBIT ANTISERA TO HUMAN IGM (MU CHAIN SPECIFIC) |
42 |
HAPTOGLOBIN SINGLE RADIAL IMMUNODIFFUSION KIT |
QUANTIPLATE OR ENDOPLATE TM HAPTOGLOBIN SINGLE RADIAL IMMUNO |
43 |
HEPATITIS A TEST |
ACCESS HAV AB |
44 |
HEPATITIS ASSAYS |
ACCESS HBC IGM |
45 |
HFSH EIA (ENZYME IMMUNOASSAY) |
ACCESS HFSH REAGENTS ON THE ACCESS IMMUNOASSAY |
46 |
HLH EIA (ENZYME IMMUNOASSAY) |
ACCESS HLH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
47 |
HORSE, GOAT, OR RABBIT ANTISERA TO HUMAN WHOLE SERUM |
HORSE, GOAT, OR RABBIT ANTISERA TO HUMAN WHOLE SERUM |
48 |
HTSH EIA |
ACCESS HTSH REAGENTS ON THE ACCESS IMMUOASSAY ANLAYZER |
49 |
HUMAN GROWTH HORMONE TEST SYSTEM |
ULTRASENSITIVE HGH ON THE ACCESS (R) IMMUNOASSAY SYSTEM |
50 |
IGA FLUORESCEIN CONJUGATED ANTISERA |
IGA FLUORESCEIN CONJUGATED ANTISERA |
51 |
IGA SINGLE RADIAL IMMUNODIFFUSION KIT |
QUANTIPLATE OR ENDOPLATE TM IGA SINGLE RADIAL IMMUNODIFFUSIO |
52 |
IGD SINGLE RADIAL IMMUNODIFFUSION KIT |
QUANTIPLATE OR ENDOPLATE TM IGD SINGLE RADIAL IMMUNODIFFUSIO |
53 |
IGE EIA |
ACCESS TOTAL IGE REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
54 |
IGG SINGLE RADIAL IMMUNODIFFUSION KIT |
QUANTIPLATE OR ENDOPLATE TM IGG SINGLE RADIAL IMMUNODIFFUSIO |
55 |
IGM FLUORESCEIN CONJUGATED ANTISERA |
IGM FLUORESCEIN CONJUGATED ANTISERA |
56 |
IGM SINGLE RADIAL IMMUNODIFFUSION KIT |
QUANTIPLATE OR ENDOPLATE TM IGM SINGLE RADIAL IMMUNODIFFUSIO |
57 |
IMMUNOELECTROPHORESIS PROFILE KIT |
IMMUNOELECTROPHORESIS PROFILE KIT |
58 |
IMMUNOLOGICAL TEST FOR 116NS19-9 ANTIBODY DEFINED ANTIGEN (CA19-9) |
GI MONITOR REAGENTS AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS |
59 |
IMMUNOLOGICAL TEST FOR CA15-3 ANTIGEN |
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS |
60 |
INHIBIN A |
ACCESS INHIBIN A |
61 |
INSULIN (ENZYME IMMUNOASSAY) |
ACCESS ULTRASENSITIVE INSULIN REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
62 |
INTRINSIC FACTOR AB CHEMILUMINESCENCE IMMUNOASSAY |
INTRINSIC FACTOR AB, INTRINSIC FACTOR AB CALIBRATORS AND INTRINSIC FACTOR AB QC |
63 |
KAPPA & LAMBDA BENCE JONES CONTROLS |
KAPPA & LAMBDA BENCE JONES CONTROLS |
64 |
LYSOZYME SINGLE RADIAL DIFFUSION KIT |
QUANTIPLATE LYSOZYME BIOLOGICAL ACTIVITY QUANTITATION KIT |
65 |
MULTIPLE |
ACCESS 2 IMMUNOASSAY SYSTEM |
66 |
MYOGLOBIN |
ACCESS MYGLOBIN REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER SYSTEMS |
67 |
OV MONITOR CHEMILUMINESCENCE |
ACCESS OV MONITOR REAGENTS AND CALIBRATORS ON THEACCESS IMMUNOASSAY SYSTEMS |
68 |
PROGESTERONE EIA (ENZYME IMMUNOASSAY) |
ACCESS PROGESTERONE REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
69 |
PROLACTIN EIA (ENZYME IMMUNOASSAY) |
ACCESS PROLACTIN REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
70 |
QUALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) |
CARDIAC QC ON THE ACCESS (R) IMMUNOASSAY SYSTEM |
71 |
QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) |
ACCUTNI (TM) QC ON THE ACCESS (R) IMMUNOSSAY SYSTEM |
72 |
RABBIT ANTISERA TO HUMAN PREALBUMIN |
RABBIT ANTISERA TO HUMAN PREALBUMIN |
73 |
RHODAMINE CONJUGATED F(AB')2 FRAGMENT GOAT ANTISERUM TO HUM |
RHODAMINE CONJUGATED F(AB')2 FRAGMENT GOAT ANTISERUM TO HUM |
74 |
SOFTWARE ACCESSORY TO AID MICROPLATE-BASED DATA & OPTICAL DENSITY READING |
EXPRESSO CARTRIDGE |
75 |
T4 EIA |
ACCESS TOTAL T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
76 |
TESTOSTERONE ASSAY |
ACESS TESTOSTERONE ASSAY |
77 |
THYROGLOBULIN ANTIBODY ENZYME IMMUNOASSAY |
ACCESS THYROGLOBULIN ANTIBODY FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS |
78 |
TOTAL BHCG EIA (ENZYME IMMUNOASSAY) |
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
79 |
TOTAL COMPLEMENT RADIAL DIFFUSION KIT |
QUANTIPLATE BIOLOGICAL ACTIVITY QUANTITATION KIT |
80 |
TOTAL PROSTATE SPECIFIC ANTIGEN |
ACCESS HYBRITECH PSA REAGENTS |
81 |
TRANSFERRIN SINGLE RADIAL IMMUNODIFFUSION KIT |
QUANTIPLATE OR ENDOPLATE TM TRANSFERRIN SINGLE RADIAL IMMUNO |
82 |
TROPONIN I ENZYME IMMUNOASSAY |
ACCUTNI (TM) AND ACCUTNI CALIBRATORS ON THE ACCESS (R) IMMUNOASSAY SYSTEM |
83 |
TUMOR ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEMS |
THYROGLOBULIN ON THE ACCESS (R) IMMUNOLOGICAL TEST SYSTEM |
84 |
TUTAKE EIA |
ACCESS TUPTAKE REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
85 |
UNCONJUGATED ESTRIOL EIA |
ACCESS UNCONJUGATED ESTRIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
86 |
VARIOUS TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS PRODUCTS |
FREE PROSTATE SPECIFIC ANTIGEN (FREE PSA) REAGENTS |
87 |
VARIOUS ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES PRODUCTS |
OSTASE ASSAYS |
88 |
VARIOUS PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS PRODUCTS |
PROSTATE SPECIFIC ANTIGEN (PSA) REAGENTS |
89 |
VITAMIN B12 EIA (ENZYME IMMUNOASSAY) |
ACCESS VITAMIN B12 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
All FDA-Registered products for this company are displayed above. |