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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 | CH - Clinical Chemistry |
| FDA Product Code | CDD |
| FDA Classification Name | RADIOASSAY, VITAMIN B12 |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 862.1810 |
| FDA Common Generic Name | B12-REAGENT |
| 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 |
AXSYM B12 | VITAMIN B12 |
| 2 | ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471 |
AXSYM B12 | VITAMIN B12 |
| 3 | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE, SCOTLAND, DD2 1XA UK 44-13-82 422000 / 441-382-422000 |
AXIS-SHIELD HOLO TC RIA | IN-VITRO DIAGNOSTIC ASSAY FOR THE MEASUREMENT OF TRANSCOBALAMIN (VITAMIN B12) |
| 4 | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383 |
ACCESS VITAMIN B12 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | VITAMIN B12 EIA (ENZYME IMMUNOASSAY) |
| 5 | BUHLMAUN LABORATORIES BASELSTRASSE 55 SCHOUENBUCH, CH-4124 SZ / 800-592-5726 |
BUHLMANN VITAMIN B6 REA | VITAMIN B6 REA |
| 6 | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820 |
MULTIPLE | [57CO] [125-I] KIT FOR SIMULTANEOUS DETERMINATION OF VITAMIN B12 AND FOLATE |
| 7 | HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845 |
RADIOASSAY, VITAMIN B12 | RADIOASSAY, VITAMIN B12 |
| 8 | MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425 |
CEDIA VITAMIN B12 /FOLATE ASSAY | VARIOUS |
| 9 | MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425 |
CEDIA VITAMIN B12-FOLATE ASSAY | VITAMIN B12 RADIOASSAY |
| 10 | MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285 |
SIMULTRAC RADIOASSAY KIT-VITAMIN 57CO/FOLATE 125I | SIMULTANEOUS RADIOASSAY FOR VITAMIN B12 AND FOLIC ACID |
| 11 | ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834 |
ELECSYS VITAMIN B12 ASSAY | VITAMIN B12 ASSAY |
| 12 | ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834 |
RADIOASSAY, VITAMIN B12 | ASSAY FOR DETERMINATION OF VITAMIN B12 |
| 13 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540 |
MAGIC LITE VITAMIN B12 ASSAY | IMMUNOASSAY |
| 14 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955 |
IMMULITE, IML 1000, IML 2500 VITAMIN B12 | IMMUNOASSAY FOR THE MEASUREMENT OF VITAMIN B12 |
| 15 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955 |
IMMULITE, IML 1000, IML 2500 VITAMIN B12 | IMMUNOASSAY FOR THE MEASUREMENT OF VITAMIN B12 |
| 16 | TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909 |
AIA-PACK B12 | IMMUNOASSAY, VITAMIN B12 |
| 17 | TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909 |
AIA-PACK B12 | VITAMIN B[BDI1][BDI2] TEST SYSTEM |
| 18 | TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909 |
AIA-PACK B12 | IMMUNOASSAY, VITAMIN B12 |
| 19 | TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909 |
AIA-PACK B12 ASSAY | IMMUNOASSAY, VITAMIN B-12 |
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