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ANA IFA
 Request for Information Form |
 Contact Information
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| Company Name | MARDX DIAGNOSTICS, INC. |
| Address | 5919 FARNSWORTH CT. |
| City, State, Zip | CARLSBAD, CA 92008 |
| Country | US |
| FDA Owner/Operator Phone | 353-127-69800 |
| FDA Medical Specialty Code | IM - Immunology |
| FDA Product Code | DHN |
| FDA Classification Name | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 866.5100 |
| FDA Common Generic Name | ANA TEST SYSTEM, HEP-2 |
| FDA Proprietary Device Name | ANA IFA |
| FDA Owner / Operator Number | 9025161 |
| FDA Owner / Operator Name | TRINITY BIOTECH, PLC |
| FDA Establishment Registration Number | 2245544 |
| FDA Registered Establishment Name | MARDX DIAGNOSTICS, INC. |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 02-15-05 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of MARDX DIAGNOSTICS, 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 | AMICO LAB, INC. 5012 ILLINOIS AVE. P.O. BOX 90203 NASHVILLE, TN 37209 US 615-385-7711 / 615-385-7711 |
ANTI-NUCLEAR ANTIBODY TEST KIT | |
| 2 | ANTIBODIES INC. 25242 CR 95 DAVIS, CA 95616 US 530-758-4400 / 530-758-4400 |
ANTIBODY TESTS, ANTINUCLEAR ANTIBODY | ANTIBODY TESTS, ANTINUCLEAR ANTIBODY |
| 3 | BION ENTERPRISES, LTD. 455 STATE STREET, SUITE 100 DES PLAINES, IL 60016 US 847-544-5044 / 847-544-5044 |
HUMAN CELL CULTURE SUBSTRATE | ANTI-NUCLEAR ANTIBODY SUBSTRATE SLIDE |
| 4 | BIO-RAD LABORATORIES, INC. 14620 N.E. NORTH WOODINVILLE WAY, SUITE 200 WOODINVILLE, WA 98072 US 425-881-8300 / 425-498-1709 |
MULTIPLE | VARIOUS MOUSE STOMACH KIDNEY AND CRITHIDIA AUTOIMMUNE IFA KITS, COMPONENTS, AND |
| 5 | BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. IRVINE, CA 92618 US 510-724-7000 / 949-598-1200 |
MULTIPLE | VARIOUS |
| 6 | DIAGNOSTIC TECHNOLOGY, INC. 175 COMMERCE DR. UNIT L HAUPPAUGE, NY 11788 US 631-582-4949 / 631-582-4949 |
ANA-CHECK TM | RAPID LATEX SLIDE TEST FOR DETECTION OF ANTINUCLEAR ANTIBODIES |
| 7 | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820 |
EL/ANA PROFILES | ENZYME IMMUNOASSAY FOR ANTINUCLEAR ANTIBODIES |
| 8 | EURO-DIAGNOSTICA AB MEDEON MALMO, S-205 12 SW / +46-40-32 11 00 |
DIASTAT ANTI-SM/RNP KIT - TEST SYSTEM | INDIRECT ELISA FOR DETECTION OF AUTOANTIBODIES TO SM/RNP |
| 9 | GENBIO 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US 858-592-9300 309 / 858-592-9300 309 |
ANA IFA | ANTINUCLEAR ANTIBODY |
| 10 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
ANA MULTIPLE DIAGNOSIS PRODUCTS | ANA MULTIPLE DIAGNOSIS PRODUCTS |
| 11 | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501 |
MULTIPLE | VARIOUS |
| 12 | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228 US 716-691-0091 / 716-691-0091 |
IMMCO DIAGNOSTICS AUTOANTIBODY TEST SYSTEM-COMVI II | ATS HEP-2 MOUSE KIDNEY STOMACH COMVI II |
| 13 | IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D SACRAMENTO, CA 95827 US 916-363-2649 / 916-363-2649 |
HEP-2000 (R) COLORZYME (R) ANA-RO TEST SYSTEM | HEP-2000 (R) COLORZYME (R) ANA-RO TEST SYSTEM |
| 14 | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131 US 858-586-9900 / 858-586-9900 351 |
NOVA LITE | VARIOUS |
| 15 | MBL INTERNATIONAL CORP. 15 B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964 |
RHIGENE HEP-ANA TEST SYSTEM | IMMUNOFLUORESCENT ANTINUCLEAR ANTIBODY TEST SYSTEM |
| 16 | MBL INTERNATIONAL CORPORATION 15B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964 |
MBL HEP-ANA TEST SYSTEM | HEP-ANA TEST SYSTEM |
| 17 | MEDICA, INC. 336 ENCINITAS BLVD., SUITE 200 ENCINITAS, CA 92024 US 760-634-5440 / 760-634-5440 |
MEDICA IIF-ANA TEST KIT | INDIRECT IMMUNOFLUORESENCE ANTI-NUCLEAR ANTIBODY TEST KIT |
| 18 | MILLIPORE AUSTRALIA PTY. LTD. 34 WADHURST DR. BORONIA, VICTORIA, 3155 AS 978-715-1399 / 978-715-1399 |
NONE | ANTINUCLEAR ANTIBODY (ANA) KIT |
| 19 | PANBIO, INC. 9075 GUILFORD RD. COLUMBIA, MD 21046 US 410-381-8550 231 / 410-381-8550 231 |
ANTINUCLEAR ANTIBODY HEP-2 INDIRECT FLUORESCENT ASSAY | INDIRECT FLURESCENT ASSAY FOR ANTINUCLEAR ANTIBODY |
| 20 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955 |
LIQUID PHASE ANTI-DNA | RADIOASSAY FOR MEASUREMENT OF ANTI-DOUBLE-STRANDED DNA |
| 21 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955 |
LIQUID PHASE ANTI-DNA | RADIOASSAY FOR MEASUREMENT OF ANTI-DOUBLE-STRANDED DNA |
| 22 | THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000 |
HEP-2 IFA KIT | HEP-2 IFA KIT |
| 23 | ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901 |
ANTINUCLEAR ANTIBODY (ANA) IFA TEST SYSTEM | ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM |
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