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MULTIPLE
 Request for Information Form |
 Contact Information
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| Company Name | ORTHO-CLINICAL DIAGNOSTICS |
| Address | FOREST FARM ESTATE WHITCHURCH |
| City, State, Zip | CARDIFF, |
| Country | UK |
| FDA Owner/Operator Phone | 585-453-4469 |
| FDA Medical Specialty Code | IM - Immunology |
| FDA Product Code | LTJ |
| FDA Classification Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 866.6010 |
| FDA Common Generic Name | PSA ASSAY |
| FDA Proprietary Device Name | MULTIPLE |
| FDA Owner / Operator Number | 9011934 |
| FDA Owner / Operator Name | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| FDA Establishment Registration Number | 9680658 |
| FDA Registered Establishment Name | ORTHO-CLINICAL DIAGNOSTICS |
| FDA Operation Code(s) |
MM - Manufacturer MS - Specification Developer |
| FDA Listing Date | 12-01-05 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of ORTHO-CLINICAL DIAGNOSTICS
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 DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471 |
MULTIPLE: AXSYM PSA, IMX PSA | PSA |
| 2 | ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471 |
MULTIPLE: AXSYM PSA, IMX PSA | PSA |
| 3 | ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. POWAY, CA 92064 US 858-513-3888 / 858-513-3888 314 |
INSTANT-VIEW PSA SERUM TEST, CASSETTE | PSA SERUM CASSETTE TEST |
| 4 | APPLIED BIOTECH 10237 FLANDERS CT. SAN DIEGO, CA 92121 US 781-674-3900 / 858-587-6771 |
MULTIPLE | PROSTATE SPECIFIC ANTIGEN - PSA |
| 5 | BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | VARIOUS |
| 6 | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383 |
PROSTATE SPECIFIC ANTIGEN (PSA) REAGENTS | VARIOUS |
| 7 | BIOCHECK, INC. 323 VINTAGE PARK DR. FOSTER CITY, CA 94404 US / 650-573-1968 |
BIOCHECK FREE PSA EIA TEST KIT | FREE PROSTATE SPECIFIC ANTIGEN (PSA) EIA TEST KIT |
| 8 | BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594 |
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) ASSAY | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| 9 | BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594 |
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) ASSAY | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| 10 | BODITECH L.L.C. 2033 ROUTE 130 UNIT-H MONMOUTH JUNCTION, NJ 08852 US 732-297-2222 102 / 732-297-2222 102 |
NONE | PSA TEST KIT |
| 11 | COVANCE RESEARCH PRODUCTS, INC. 180 RUSTCRAFT RD., SUITE 140 DEDHAM, MA 02026 US 800-922-2226 / 781-915-1405 |
P.S.A., POLYCLONAL ANTIBODY | P.S.A., POLYCLONAL ANTIBODY |
| 12 | CTK BIOTECH, INC. 6748 NANCY RIDGE DR. SAN DIEGO, CA 92121 US 858-457-8698 / 858-457-8698 |
PSA DETECT ELISA KIT | PSA DETECT KIT |
| 13 | DAIICHI PURE CHEMICALS CO., LTD. 3-1, KOYODAI 3-CHOME, RYUGASAKI-CITY IBARAKI, 301-0852 JA 011-029-7627551 / 617-768-6275 |
NANOPIA PSA, VITALAB PSA, SELECTRA PSA, CLINICAL DATA PSA | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY |
| 14 | DAKO DENMARK A/S 42 PRODUKTIONSVEJ GLOSTRUP, DK-2600 DA 454-485-9500 / 45-88-305171 |
MOUSE ANTI-HUMAN PROSTATE SPECIFIC ANTIGEN, ER-PR8 M0750 | PROSTATE SPECIFIC ANTIGEN ANTIBODY |
| 15 | DAKO NORTH AMERICA, INC. 6392 VIA REAL CARPINTERIA, CA 93013 US 454-485-9500 / 805-566-6655 5487 |
MOUSE ANTI-HUMAN PROSTATE SPECIFIC ANTIGEN, ER-PR8 M0750 | PROSTATE SPECIFIC ANTIGEN ANTIBODY |
| 16 | GENETIC TECHNOLOGIES INC. 6157 N.W. 167TH ST., F-26 MIAMI, FL 33015 US 305-828-3818 / 305-828-3818 |
PSA MICROPLATE ELISA | PSA ELISA |
| 17 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
GLOBALEMED FREE PSA EIA | FREE PROSTATE SPECIFIC ANTIGEN (PSA) EIA TEST |
| 18 | MONOBIND, INC. 100 N. POINTE DR. LAKE FOREST, CA 92630 US 949-951-2665 / 949-951-2665 |
PSA MICROPLATE ELISA | PSA ELISA |
| 19 | QUALIGEN, INC. 2042 CORTE DEL NOGAL CARLSBAD, CA 92011 US 760-918-9165 / 760-918-9165 226 |
MULTIPLE | VARIOUS |
| 20 | RAPID DIAGNOSTICS 1429 ROLLINS RD. BURLINGAME, CA 94010 US 949-833-2500 / 949-833-2500 |
RAPID PSA TEST | PSA TEST |
| 21 | ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834 |
ELECSYS PSA ASSAY | PSA ASSAY |
| 22 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 80 ROGERS STREET CAMBRIDGE, MA 02142 US 914-524-2955 / 617-492-7289 310 |
MULTIPLE | VARIOUS |
| 23 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540 |
ACS PROSTRATE SPECIFIC ANTIGEN (PSA) ASSAY | ACS PROSTRATE SPECIFIC ANTIGEN (PSA) |
| 24 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955 |
RIA, IMMULITE 1000, 2000, 2500 PSA, 3RD GEN. PSA | IMMUNOASSAY FOR DETECTION & QUANT. OF MICROALBUMINURIA |
| 25 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
BAYER IMMUNO 1 COMPLEXED PSA ASSAY FOR DETECTION AND MONITORING OF PROSTATE CANC | CPSA ASSAY FOR BAYER IMMUNO 1 ANALYZER |
| 26 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955 |
RIA, IMMULITE, IML 2000, IML 2500 PSA, 3RD GEN. PSA | IMMUNOASSAY FOR DETECTION & QUANT. OF MICROALBUMINURIA |
| 27 | ST. PAUL BIOTECH 11555 MONARCH ST. GARDEN GROVE, CA 92841 US 714-903-1000 / 714-903-1000 226 |
MULTIPLE | PSA TEST |
| 28 | TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909 |
AIA-PACK PA, ST AIA-PACK PA | FOR THE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN, PSA |
| 29 | TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909 |
AIA-PACK PA, ST AIA-PACK PA | FOR THE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN, PSA |
| 30 | TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909 |
AIA-PACK PA | FOR THE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN |
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