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ANA CENTROMERE CONTROL, ANA NUCLEOLAR CONTROL, ANA SPECKLED CONTROL
 Request for Information Form |
 Contact Information
|
| 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 |
LKJ |
| FDA Classification Name |
ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL |
| FDA Device Classification Code |
Standards
|
| FDA Regulation Number |
866.5100
|
| FDA Common Generic Name |
ANA CENTROMERE CONTROL, ANA NUCLEOLAR CONTROL, ANA SPECKLED CONTROL |
| FDA Proprietary Device Name |
ANA CENTROMERE CONTROL, ANA NUCLEOLAR CONTROL, ANA SPECKLED CONTROL |
| 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 |
05-05-05 |
| 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 |
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
4000 ALFRED NOBEL DR.
HERCULES, CA 94547 US
510-724-7000 / 510-741-6263
|
ENZYME IMMUNOASSAY ANTINUCLEAR ANTIBODY SCREENING TEST KIT |
ENZYME IMMUNOASSAY ANTINUCLEAR ANTIBODY SCREENING TEST KIT |
| 2 |
BIO-RAD LABORATORIES, INC.
6565 185TH AVE., N.E.
REDMOND, WA 98052 US
425-881-8300 / 425-498-1709
|
BIOPLEX 2200 ANA SCREEN REAGENT PACK AND ACCESSORIES |
MULTI-ANALYTE DETECTION SYSTEM-ANA SCREEN |
| 3 |
BIO-RAD LABORATORIES, INC.
14620 N.E. NORTH WOODINVILLE
WAY, SUITE 200
WOODINVILLE, WA 98072 US
425-881-8300 / 425-498-1709
|
BIOPLEX 2200 ANA SCREEN REAGENT PACK AND ACCESSORIES |
MULTI-ANALYTE DETECTION SYSTEM-ANA SCREEN |
| 4 |
BIO-RAD, DIAGNOSTICS GRP.
9500 JERONIMO RD.
IRVINE, CA 92618 US
510-724-7000 / 949-598-1200
|
MULTIPLE |
VARIOUS |
| 5 |
CORGENIX, INC.
11575 MAIN ST.
SUITE 400
BROOMFIELD, CO 80020 US
303-457-4345 / 303-457-4345 130
|
REAADS DSDNA QUANTITATIVE TEST KIT |
ANTI-DSDNA ENZYME IMMUNOASSAY TEST KIT |
| 6 |
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI, FL 33127 US
305-324-2300 / 305-324-2354
|
IS- ANA ELISA SCREEN |
ANA ELISA |
| 7 |
GENBIO
15222 AVE. OF SCIENCE, SUITE A
SAN DIEGO, CA 92128 US
858-592-9300 309 / 858-592-9300 309
|
IMMUNO DOT AUTOIMMUNITY SCREENING PANEL 4 |
ENZYME-LINKED DOT-BLOT IMMUNOASSAY ANTINUCLEAR ANTIBODIES |
| 8 |
HYCOR BIOMEDICAL LTD.
PENTLANDS SCIENCE PARK
BUSH LOAN
EDINBURGH, EH26 OPL UK
44-131-445 7111 / 44-131-445 7111
|
MULTIPLE |
VARIOUS |
| 9 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
5210 PACIFIC CONCOURSE DR.
LOS ANGELES, CA 90045 US
914-524-2955 / 914-524-2955
|
ANALINE BLOT |
ANTINUCLEAR AB SCREENING TEST FOR IDENTIFICATION OF IGG AB IN |
| 10 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
5700 WEST 96TH ST.
LOS ANGELES, CA 90045 US
914-524-2955 / 914-524-2955
|
ANALINE BLOT |
ANTINUCLEAR AB SCREENING TEST FOR IDENTIFICATION OF IGG AB IN |
| 11 |
THERATEST LABORATORIES, INC.
1111 N. MAIN ST.
LOMBARD, IL 60148 US
630-627-6069 / 630-627-6069
|
EL-ANA |
ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL |
| 12 |
TRINITY BIOTECH USA
2823 GIRTS RD.
JAMESTOWN, NY 14701 US
353-127-69800 / 716-483-3851
|
ENCORE SCL-70 EIA |
ELISA FOR ANTIBODY TO SCL-70 |
| 13 |
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG, NJ 08876 US
908-526-3744 / 908-243-4901
|
ATHENA MULTI-LYTE(R) ANA TEST SYSTEM |
ANA TEST SYSTEM |
|
