|
FDA-Registered Company Profile for SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
|
| FDA-Supplied Establishment Information: |
|
| Establishment Registration Number: |
2432235 |
| Company Name: |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
| Address: |
511 BENEDICT AVENUE |
| Address 2: |
|
| City: |
TARRYTOWN |
| State |
NY |
| Zip / Postal Code: |
10591 |
| County: |
WESTCHESTER |
| Country: |
US |
| Establishment Operation Code(s): |
AA - Initial Distributor
MM - Manufacturer
MS - Specification Developer
|
| Establishment Status Code: |
A -
Active
|
Year of Most Recent Initial or Annual Registration: |
2007 |
| FDA-Supplied Owner/Operator Information: |
| Owner/Operator Number: |
9096044 |
| Company Name: |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
|
| Address: |
511 BENEDICT AVENUE |
| Address 2: |
|
| City: |
TARRYTOWN |
| State: |
NY |
| Zip / Postal Code: |
10591 |
| Country: |
US |
| Owner/Operator Phone: |
914-524-2955
|
| FDA-Supplied Official Correspondent Information: |
| Official Correspondent Name: |
DR. FRANK LADUCA |
| Company Name: |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
| Address: |
511 BENEDICT AVENUE |
| Address 2: |
|
| City: |
TARRYTOWN |
| State: |
NY |
| Zip / Postal Code: |
10591 |
| Country: |
US |
| Official Corespondent Phone Number: |
914-524-2955
|
 |
 |
| Other Establishment Information: |
| Establishment Phone: |
|
| Fax: |
|
| General Email: |
|
| Web Site: |
http://www.bayerhealthcare.com
|
| Company Brochure: |
|
| Keywords: |
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| Company Description: |
|
| Services Offered: |
|
| About Us: |
|
| Differentiation: |
|
FDA-Registered Products Offered by SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
|
|
Common Device Name |
Proprietary Device Name |
| 1 |
16-CHANNEL BLOODTYPING SYSTEM |
TECHNICON AUTOGROUPER 16-C SYSTEM |
| 2 |
ACID PHOSPHATASE ASSAY |
MULTIPLE PRODUCT NAMES |
| 3 |
ACS PHENYTOIN ASSAY |
ACS PHENYTOIN ASSAY |
| 4 |
ACS VANCOMYCIN ASSAY |
ACS VANCOMYCIN ASSAY |
| 5 |
ADVIA 1650 REAGENT |
ADVIA 1650 REAGENT SPECIFIC PROTEIN CALIBRATOR, LOW |
| 6 |
ADVIA 1650 REAGENT C-REACTIVE PROTEIN CALIBRATOR |
ADVIA 1650 REAGENT C-REACTIVE PROTEIN CALIBRATOR |
| 7 |
ADVIA 1650 REAGENT URINALYSIS CONTROL AND ABNORMAL CONTROL |
ADVIA 1650 REAGENT TESTPOINT URINE CONTROL AND ABNORMAL CONTROL |
| 8 |
ALBUMIN ASSAY |
ADVIA 1650 ALBUMIN ASSAY |
| 9 |
ALKALINE PHOSPHATASE - AMP ASSAY |
ADVIA 1650 ALKALINE PHOSPHATASE - AMP ASSAY |
| 10 |
AMMONIA ASSAY |
MULTIPLE PRODUCT NAMES |
| 11 |
AMPHETAMINE ASSAY |
ADVIA CHEMISTRY AMPHETAMINE TEST |
| 12 |
AMYLASE ASSAY |
ADVIA 1650 AMYLASE ASSAY |
| 13 |
ANTI-STREPTOLYSIN O TEST SYSTEM |
MULTIPLE PRODUCT NAMES |
| 14 |
ASPARTATE AMINOTRANSFERASE ASSAY |
ADVIA 1650 ASPARTATE AMINOTRANSFERASE ASSAY |
| 15 |
ASR HER 2/NEU P105 ANTIGEN SOLUTION |
BAYER HER-2/NEU ASSAY ANALYTE SPECIFIC REAGENT (ASR) |
| 16 |
AUTOMATED COMPLETE BLOOD CELL & DIFFERENTIAL CELL COUNTER |
ADVIA 120 HEMATOLOGY SYSTEM, INVITRO DIAGNOSTIC SYSTEM |
| 17 |
AUTOMATED SLIDE STAINER |
ADIVA S60 |
| 18 |
AUTOMATED, COMPUTER CONTROLLED, RADIOIMMUNOASSAY SYSTEM |
TECHNICON STAR SYSTEM |
| 19 |
AUTOTECHNICON ULTRA; ULTRA II; AUTOTECHNICON MONO, DUO |
AUTOTECHNICON ULTRA, ULTRA II, MONO AND DUO AUTOMATED TISSUE |
| 20 |
BARBITURATE ASSAY |
ADVIA CHEMISTRY BARBITURATE TEST |
| 21 |
BENZODIAZEPINE ASSAY |
ADVIA CHEMISTRY BENZODIAZEPINE TEST |
| 22 |
BETA 2 MICROGLOBULIN TEST SYSTEM |
MULTIPLE PRODUCT NAMES |
| 23 |
BILIRUBIN, DIRECT ASSAY |
ADVIA 1650 BILIRUBIN, DIRECT ASSAY |
| 24 |
BNP ASSAY |
MULTIPLE PRODUCT NAMES |
| 25 |
C-REACTIVE TEST SYSTEM |
C-REACTIVE TEST SYSTEM |
| 26 |
CA 19-9 ASSAY |
MULTIPLE PRODUCT NAMES |
| 27 |
CALCIUM ASSAY |
ADVIA 1650 CALCIUM ASSAY |
| 28 |
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| 29 |
CALIBRATOR |
MULTIPLE PRODUCT NAMES |
| 30 |
CANNABINOID ASSAY |
ADVIA CHEMISTRY CANNABINOID TEST |
| 31 |
CARBAMAZEPINE TEST SYSTEM |
MULTIPLE PRODUCT NAMES |
| 32 |
CARBON DIOXIDE ASSAY |
BAYER ADVIA 1650 CARBON DIOXIDE (C02) ASSAY |
| 33 |
CHLORIDE ASSAY |
BAYER 1650 CHLORIDE ASSAY |
| 34 |
CHOLESTEROL ASSAY |
ADVIA 1650 CHOLESTEROL TEST SYSTEM |
| 35 |
CHOLINESTERASE ASSAY |
CHOLINESTERASE ASSAY FOR THE ADVIA 1650 |
| 36 |
CLINICAL ANALYZER |
ADIVA CENTAUR CP ANALYZER |
| 37 |
COCAINE METABOLITE ASSAY |
ADVIA CHEMISTRY COCAINE METABOLITE TEST |
| 38 |
CPSA ASSAY FOR BAYER IMMUNO 1 ANALYZER |
BAYER IMMUNO 1 COMPLEXED PSA ASSAY FOR DETECTION AND MONITORING OF PROSTATE CANC |
| 39 |
CREATINE KINASE ASSAY |
ADVIA 1650 CREATINE KINASE ASSAY |
| 40 |
CREATININE, ENYMATIC ASSAY |
ADVIA 1650 CREATININE, ENYMATIC ASSAY |
| 41 |
CREATININE, JAFFE ASSAY |
ADVIA 1650 CREATININE, JAFFE ASSAY |
| 42 |
DIGITOXIN TEST SYSTEM |
MULTIPLE PRODUCT NAMES |
| 43 |
DIOGOXIN REAGENTS |
MULTIPLE PRODUCT NAMES |
| 44 |
DRUG MIXTURE CONTROL MATERIALS~CLINICAL TOXICOLOGY |
DRUG MIXTURE CONTROL MATERIALS~CLINICAL TOXICOLOGY |
| 45 |
ESTRADIOL TEST SYSTEM |
MULTIPLE PRODUCT NAMES |
| 46 |
ETHANOL ASSAY |
MULTIPLE PRODUCT NAMES |
| 47 |
FOLIC ACID ASSAY |
MULTIPLE PRODUCT NAMES |
| 48 |
GAMMA GLUTAMYL TRANSFERASE (GGT) ASSAY |
ADVIA 1650 GAMMA GLUTAMYL TRANSFERASE (GGT) TEST SYSTEM |
| 49 |
GENTAMICIN TEST SYSTEM |
MULTIPLE PRODUCT NAMES |
| 50 |
GLUCOSE - OXIDASE ASSAY |
ADVIA 1650 GLUCOSE - OXIDASE ASSAY |
| 51 |
GLUCOSE HEXOKINASAE ASSAY |
GLUCOSE HEXOKINASAE II ASSAY FOR THE ADVIA 1650 |
| 52 |
HDL CHOLESTEROL ASSAY |
ADVIA 1650 HDL CHOLESTEROL ASSAY |
| 53 |
HEMATOLOGY STAIN |
MULTIPLE PRODUCT NAMES |
| 54 |
HEMATOLOGY STAIN |
MULTIPLE PRODUCT NAMES |
| 55 |
HEMATOLOGY STAIN |
MULTIPLE PRODUCT NAMES |
| 56 |
HEMOGLOBIN A1C ASSAY |
MULTIPLE PRODUCT NAMES |
| 57 |
HEMOGLOBIN CALIBRATOR |
MULTIPLE PRODUCT NAMES |
| 58 |
HEPATITIS ASSAYS |
ADVIA CENTAUR HEPATITIS B ASSAYS |
| 59 |
HEPATITIS C ASSAY |
ADVIA CENTAUR HEPATITIS C ASSAY |
| 60 |
HER-2/NEU ASSAY |
MULTIPLE PRODUCT NAMES |
| 61 |
HER-2/NEU ASSAY FOR BAYER IMMUNO 1 ANALYZER |
BAYER IMMUNO 1 HER-2/NEU ASSAY, FOR FOLLOW-UP AND MONITORING PATIENTS WITH METAS |
| 62 |
HOMOCYSTEINE ASSAY |
HOMOCYSTEINE ASSAY FOR THE ACS:180 & CENTAUR |
| 63 |
IMMUNOGLOBULIN A (IGA) ASSAY |
BAYER ADVIA 1650 IMMUNOGLOBULIN A (IGA) ASSAY |
| 64 |
IMMUNOGLOBULIN G (IGG) ASSAY |
ADVIA 1650 IMMUNOGLOBULIN G (IGG) ASSAY |
| 65 |
IMMUNOGLOBULIN M (IGM) ASSAY |
ADVIA 1650 IMMUNOGLOBULIN M (IGM) ASSAY |
| 66 |
INORGANIC PHOSPHORUS ASSAY |
ADVIA 1650 INORGANIC PHOSPHORUS ASSAY |
| 67 |
IRON ASSAY |
ADVIA 1650 IRON ASSAY |
| 68 |
LACTATE DEHYDROGENASE (LDH) ASSAY |
ADVIA 1650 LACTATE DEHYDROGENASE (LDH) TEST SYSTEM |
| 69 |
LACTIC ACID ASSAY |
MULTIPLE PRODUCT NAMES |
| 70 |
LE TEST REAGENT KIT |
NO PROPRIETARY NAME LISTED |
| 71 |
LIPOPROTEIN ASSAY |
BAYER 1650 APOLIPOPROTEIN (APO-A) ASSAY |
| 72 |
LIPOPROTEIN ASSAY |
BAYER ADVIA 1650 APOLIPOPROTEIN (APO-B) ASSAY |
| 73 |
MAGNESIUM ASSAY |
ADVIA 1650 MAGNESIUM ASSAY |
| 74 |
METHADONE TEST |
ADVIA CHEMISTRY METHADONE TEST |
| 75 |
MICROALBUMIN ASSAY |
BAYER ADVIA 1650 MICROALBUMIN TEST SYSTEM |
| 76 |
MICROSCOPE SLIDES |
MULTIPLE PRODUCT NAMES |
| 77 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 78 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 79 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 80 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 81 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 82 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 83 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 84 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 85 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 86 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 87 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 88 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 89 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 90 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 91 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 92 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 93 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 94 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 95 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 96 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 97 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 98 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 99 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 100 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 101 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 102 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 103 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 104 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 105 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 106 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 107 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 108 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 109 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 110 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 111 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 112 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 113 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 114 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 115 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 116 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 117 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 118 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 119 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 120 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 121 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 122 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 123 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 124 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 125 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 126 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 127 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 128 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 129 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 130 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 131 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 132 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 133 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 134 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 135 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 136 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 137 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 138 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 139 |
NO COMMON NAME LISTED |
NO PROPRIETARY NAME LISTED |
| 140 |
OPIATE ASSAY |
ADVIA CHEMISTRY OPIATE TEST |
| 141 |
PARATHYROID HORMONE ASSAY |
BAYER DIAGNOSTICS ACS:180 & ADVIA CENTAUR INTACT PTH ASSAY |
| 142 |
PARATHYROID HORMONE ASSAY |
BAYER DIAGNOSTICS ACS:180 & ADVIA CENTAUR INTACT PTH ASSAY |
| 143 |
PHENCYCLIDINE ASSAY |
ADVIA CHEMISTRY PHENCYCLIDINE TEST |
| 144 |
PHENOBARBITAL TEST SYSTEM |
MULTIPLE PRODUCT NAMES |
| 145 |
PHENYTOIN REAGENTS/ MULTIPLE |
PHENYTOIN REAGENTS/ MULTIPLE |
| 146 |
POTASSIUM ASSAY |
ADVIA 1650 POTASSIUM ASSAY |
| 147 |
PREALBUMIN ASSAY |
MULTIPLE PRODUCT NAMES |
| 148 |
PROPOXYPHENE ASSAY |
ADVIA CHEMISTRY PROPOXYPHENE TEST |
| 149 |
RANDOM ACCESS CHEMISTRY ANALYZER |
TECHNICON RA-1000 SYSTEM |
| 150 |
SODIUM ASSAY |
ADVIA 1650 SODIUM ASSAY |
| 151 |
SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
| 152 |
TECHNICON D/90 ANALYZER |
TECHNICON D/90 AUTOMATED LEUKOCYTE DIFFERENTIAL ANALYZER |
| 153 |
TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) |
TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) |
| 154 |
THC CALIBRATOR |
ADVIA CHEMISTRY THC 50 CALIBRATOR |
| 155 |
THC CONTROL MATERIAL |
ADVIA CHEMISTRY THC 40, 60 CONTROLS |
| 156 |
THEOPHYLLINE ASSAY |
BAYER DIAGNOSTICS ACS:180 & ADVIA CENTAUR THEOPHYLLINE ASSAY |
| 157 |
THYROID AUTOANTIBODY IMMUNOLOIGCAL ASSAY |
THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM FOR ADVIA CTR. & ACS:180 |
| 158 |
TOTAL PROTEIN (URINE) ASSAY |
MULTIPLE PRODUCT NAMES |
| 159 |
TOTAL PROTEIN ASSAY |
ADVIA 1650 TOTAL PROTEIN TEST SYSTEM |
| 160 |
TRANSFERRIN ASSAY (TRF) |
ADVIA 1650 TRANSFERRIN (TRF) ASSAY |
| 161 |
TRIGLYCERIDE ASSAY |
ADVIA 1650 TRIGLYCERIDE TEST SYSTEM |
| 162 |
TROPONIN I ASSAY |
MULTIPLE PRODUCT NAMES |
| 163 |
UREA NITROGEN ASSAY |
ADVIA UREA NITROGEN ASSAY |
| 164 |
URIC ACID ASSAY |
ADVIA 1650 URIC ACID ASSAY |
| 165 |
VALPROIC ACID ASSAY |
ADVIA CENTAUR & ACS:180 VALPROIC ACID ASSAY |
| 166 |
VALPROIC ACID ASSAY |
ADVIA CENTAUR & ACS:180 VALPROIC ACID ASSAY |
| 167 |
VARIOUS PROTEUS ANTIGENS |
NO PROPRIETARY NAME LISTED |
| All FDA-Registered products for this company are displayed above. |