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APOLIPOPROTEIN
 Request for Information Form |
 Contact Information
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| Company Name | ROCHE DIAGNOSTICS CORP. |
| Address | 9115 HAGUE RD. |
| City, State, Zip | INDIANAPOLIS, IN 46250 |
| Country | US |
| FDA Owner/Operator Phone | -- |
| FDA Medical Specialty Code | IM - Immunology |
| FDA Product Code | DFC |
| FDA Classification Name | LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 866.5600 |
| FDA Common Generic Name | APOLIPOPROTEIN |
| FDA Proprietary Device Name | APOLIPOPROTEIN |
| FDA Owner / Operator Number | 1823260 |
| FDA Owner / Operator Name | ROCHE HOLDING, INC. |
| FDA Establishment Registration Number | 1823260 |
| FDA Registered Establishment Name | ROCHE DIAGNOSTICS CORP. |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 08-24-94 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of ROCHE DIAGNOSTICS CORP.
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 | AXIS-SHIELD ASA 87 ULVENVEIEN OSLO, N-0581 NO 47-22-700600 / 47-22-042000 |
IMX HOMOCYSTEINE | HOMOCYSTEINE ASSAY |
| 2 | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE, SCOTLAND, DD2 1XA UK 44-13-82 422000 / 441-382-422000 |
ABBOTT IMX(R) HOMOCYSTEINE | HOMOCYSTEINE ASSAY |
| 3 | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. BREA, CA 92821 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | VARIOUS |
| 4 | BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | VARIOUS |
| 5 | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383 |
GOAT ANTISERA TO HUMAN BETA-LIPOPROTEIN | GOAT ANTISERA TO HUMAN BETA-LIPOPROTEIN |
| 6 | BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383 |
MULTIPLE | VARIOUS |
| 7 | BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000 |
MULTIPLE (QUANTIA LP(A)) | LP(A) LATEX AGGLUTINATION TEST |
| 8 | CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272 |
LP(A) ASSAY | LP(A) CALIBRATOR AND CONTROL |
| 9 | DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311 |
N LATEX LP(A) REAGENT | LIPOPROTEIN TEST |
| 10 | DENKA SEIKEN CO., LTD (KAGAMIDA FACILITY) 1359-1, KAGAMIDA, KIGOSHI GOSEN-SHI, NIIGATA, 959-1834 JA 81-3-36699421 / 81-250-420812 |
LP(A)-LATEX SEIKEN ASSAY KIT | LP(A) LATEX REAGENT |
| 11 | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820 |
MULTIPLE | TURBIDIMETRIC ASSAY FOR APOLIPOPROTEIN B,ANTI-HUMAN LOW DENSITY LIPOPROTEIN SERU |
| 12 | GENZYME CORPORATION ONE KENDALL SQUARE CAMBRIDGE, MA 02139 US 617-252-7500 / 617-768-6275 |
MULTIPLE | LIPOPROTEIN TEST SYSTEM; LOW DENSITY LIPOPROTEIN CHOLESTEROL TEST |
| 13 | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068 |
K-ASSAY LP(A) ASSAY | LIPOPROTEIN(A) ASSAY KIT |
| 14 | NITTO BOSEKI CO., LTD. (MEDICAL DIVISION) 4-1-28 KUDAN-KITA CHIYODA-KU TOKYO, 102-0073 JA 81-3-32384540 / 206-575-8068 |
N-ASSAY TIA LP(A) | LIPOPROTEIN(A) ITA |
| 15 | POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363 |
POLYMEDCO POLY-CHEM SYSTEM, LIPOPROTEIN (A) | LIPOPROTEIN (A), LP(A) |
| 16 | RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413 |
RANDOX LIPOPROTEIN A | LIPOPROTEIN A |
| 17 | RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413 |
RANDOX LIPOPROTEIN A | LIPOPROTEIN A |
| 18 | RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413 |
RANDOX LIPOPROTEIN A | LIPOPROTEIN A |
| 19 | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413 |
RANDOX LIPOPROTEIN A | LIPOPROTEIN A |
| 20 | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501 |
RAICHEM;SPIA;APO B REAGENT | REAGENT FOR APOLIPOPROTEIN SETERMINATION, IMMUNOLOGICAL |
| 21 | STRATEGIC DIAGNOSTICS, INC. 128 SANDY DR. NEWARK, DE 19713 US 302-456-6785 264 / 302-456-6785 264 |
MACRA, LP(A) ENZYME IMMUNOASSAY KIT | LP(A) TEST KIT; LIPOPROTEIN (A) TEST KIT |
| 22 | STRATEGIC DIAGNOSTICS, INC. 111 PENCADER DR. NEWARK, DE 19702 US 302-456-6785 264 / 302-456-6785 220 |
MACRA LP(A) ENZYME IMMUNOASSAY TEST KIT | LP(A) TEST KIT; LIPOPROTEIN (A) TEST KIT |
| 23 | TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851 |
MULTIPLE | VARIOUS TYPES OF LP(A) ENZYME IMMUNOASSAY KITS |
| 24 | WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US 816-620-33741 / 650-210-9153 109 |
AUTOKIT APO B | APOLIPROTEIN TEST KIT |
| 25 | WAKO PURE CHEMICAL INDUSTRIES, LTD. 2613-2 OAZA OGOHARA KOMONO-CHO MIE, 510-1222 JA 816-620-33741 / 650-210-9153 109 |
AUTOKIT APO B | APOLIPOPROTEIN TEST KIT |
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