|
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: |
|
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. |