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AIA-PACK CA 19-9, ST AIA-PACK CA 19-9
 Request for Information Form |
 Contact Information
|
| Company Name |
TOSOH BIOSCIENCE, INC.
|
| Address |
6000 SHORELINE COURT
SUITE 101
|
| City, State, Zip |
SOUTH SAN FRANCISCO, CA 94080 |
| Country |
US |
| FDA Owner/Operator Phone |
813-542-75118 |
| FDA Medical Specialty Code |
IM - Immunology
|
| FDA Product Code |
NIG |
| FDA Classification Name |
SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER |
| FDA Device Classification Code |
Standards
|
| FDA Regulation Number |
866.6010
|
| FDA Common Generic Name |
CARBOHYDRATE ANTIGEN, CA 19-9, FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCE |
| FDA Proprietary Device Name |
AIA-PACK CA 19-9, ST AIA-PACK CA 19-9 |
| FDA Owner / Operator Number |
8031673 |
| FDA Owner / Operator Name |
TOSOH CORP. |
| FDA Establishment Registration Number |
2950409 |
| FDA Registered Establishment Name |
TOSOH BIOSCIENCE, INC. |
| FDA Operation Code(s) |
RR - Repackager/Relabeller
|
| FDA Listing Date |
05-09-05 |
| FDA Listing Status Code |
Active
|
| Differentiation |
N/A |
| Keywords |
N/A |
| Description |
N/A |
| Brochure |
N/A |
| Product Website
|
N/A |
Competitors of TOSOH BIOSCIENCE, INC.
Our records indicate that the following medical device companies may manufacture a similar device.
| |
Company Name / Address / Phone |
Proprietary Device Name |
Common Generic Device Name |
| 1 |
ABBOTT LABORATORIES
100 AND 200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064 US
847-937-6100 / 847-938-3471
|
ARCHITECT CA19-9 |
CARBOHYDRATE ANTIGEN (CA19-9) |
| 2 |
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318 US
714-871-4848 / 714-993-5321 8383
|
GI MONITOR REAGENTS AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS |
IMMUNOLOGICAL TEST FOR 116NS19-9 ANTIBODY DEFINED ANTIGEN (CA19-9) |
| 3 |
FUJIREBIO DIAGNOSTICS, INC.
201 GREAT VALLEY PKWY.
MALVERN, PA 19355 US
/ 610-240-3829
|
FUJIREBIO DIAGNOSTICS CA 19-9 RIA |
IMMUNOLOGICAL TEST FOR 1116N519-9 ANTIBODY DEFINED ANTIGEN (CA19-9) |
| 4 |
ORTHO-CLINICAL DIAGNOSTICS
FOREST FARM ESTATE WHITCHURCH
CARDIFF, CF14 7YT UK
585-453-4469 / 585-453-4152
|
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 19-9 REAGENT PACK |
VITROS CA 19-9 |
| 5 |
ROCHE DIAGNOSTICS GMBH
NONNENWALD 2
PENZBERG, D-82377 GM
49-621-7670 / 317-521-2834
|
ELECSYS CA 19-9 |
IMMUNOASSAY-CANCER MARKER |
| 6 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 BENEDICT AVENUE
TARRYTOWN, NY 10591 US
914-524-2955 / 914-524-2955
|
MULTIPLE |
CA 19-9 ASSAY |
| 7 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
333 CONEY ST.
WALPOLE, MA 02032 US
914-524-2955 / 508-660-8540
|
MULTIPLE |
CA 19-9 ASSAY |
| 8 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
GLYN RHONWY
LLANBERIS, CAERNARFON, LL55 4EL UK
914-524-2955 / 914-524-2955
|
IMMULITE GI-MA (CA19-9) |
IMMUNOASSAY FOR THE MEASUREMENT OF CA19-9 |
| 9 |
TOSOH AIA, INC.
2, IWASEKOSHI-MACHI
TOYAMA, 931-8510 JA
813-542-75118 / 614-317-1909
|
AIA-PACK CA 19-9, ST AIA-PACK CA 19-9 |
CARBOHYDRATE ANTIGEN, CA 19-9, FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCE |
| 10 |
TOSOH BIOSCIENCE, INC.
3600 GANTZ ROAD
GROVE CITY, OH 43123 US
813-542-75118 / 614-317-1909
|
AIA-PACK CA 19-9, ST AIA-PACK CA 19-9 |
TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM |
|
