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DIMERTEST LATEX ASSAY
 Request for Information Form |
 Contact Information
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| Company Name | AGEN BIOMEDICAL LTD. |
| Address | 7 & 11 DURBELL ST.,
ACACIA RIDGE |
| City, State, Zip | BRISBANE, QUEENSLAND, |
| Country | AS |
| FDA Owner/Operator Phone | 61-733-706300 |
| FDA Medical Specialty Code | HE - Hematology |
| FDA Product Code | DAP |
| FDA Classification Name | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 864.7320 |
| FDA Common Generic Name | D-DIMER TEST (FIBRIN DEGRADATION PRODUCTS ASSAY) |
| FDA Proprietary Device Name | DIMERTEST LATEX ASSAY |
| FDA Owner / Operator Number | 8020026 |
| FDA Owner / Operator Name | AGEN BIOMEDICAL LTD. |
| FDA Establishment Registration Number | 8020026 |
| FDA Registered Establishment Name | AGEN BIOMEDICAL LTD. |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 04-18-06 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of AGEN BIOMEDICAL LTD.
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 | AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE STAMFORD, CT 06902 US 203-602-7777 / 203-602-7777 |
MULTIPLE | VARIOUS |
| 2 | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383 |
ACCESS D-DIMER REAGENT | FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY |
| 3 | BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000 |
MULTIPLE | D-DIMER CONTROLS |
| 4 | BIOMERIEUX BV BOSEIND 15 BOXTEL, 5280 AB NL 33-478-872063 / 314-731-8594 |
FIBRINOSTIKA FGDP MICROELISA SYSTEM | FIBINOGEN DEGRADATION PRODUCT |
| 5 | BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594 |
VIDAS D DIMER (DD) ASSAY | ENZYME-LINKED FLURESCENT IMMUNOASSAY (ELFA) FOR THE DETECTION OF D. DIMER |
| 6 | BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594 |
VIDAS D DIMER (DD) ASSAY | ENZYME-LINKED FLURESCENT IMMUNOASSAY (ELFA) FOR THE DETECTION OF D. DIMER |
| 7 | BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US 781-674-3900 / 858-805-3423 |
TRIAGE PROFILER S.O.B. PANEL | FLUORESCENCE IMMUNOASSAY FOR CKMB,TNL,MYOGLOBIN,ONP & D-DIMER |
| 8 | CLINICAL CONTROLS INTERNATIONAL 1236 LOS OSOS VALLEY ROAD SUITE T LOS OSOS, CA 93402 US 805-528-4039 / 805-528-4039 |
FIBRINOGEN FDP CONTROL | FIBRINOGEN FDP CONTROL |
| 9 | DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311 |
MULTIPLE | DETERMINATION OF FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, D-DIMER |
| 10 | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311 |
D-DIMER CAL | D-DIMER CAL |
| 11 | DIAGNOSTICA STAGO 23/29 RUE CONSTANTIN PECQUER TAVERNY, 95150 FR 33-146-88 20 20 / 33-146-854851 |
MULTIPLE | VARIOUS |
| 12 | DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851 |
MULTIPLE | VARIOUS |
| 13 | FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163 |
PACIFIC HEMOSTASIS THROMBOSCREEN FDP ASSAY SET | FIBRINOGEN DEGRADATION PRODUCTS ASSAY |
| 14 | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068 |
K-ASSAY D-DIMER ASSAY, CALIBRATOR, CALIBRATOR DILUENT | D-DIMER ASSAY, CALIBRATOR, CALIBRATOR DILUENT |
| 15 | KENT LABORATORIES, INC. 777 JORGENSEN PLACE BELLINGHAM, WA 98226 US 360-398-8641 / 360-398-8641 |
ANTI HUMAN FIBRINOGEN & FIBRIN ANTISERUM | |
| 16 | MORE DIAGNOSTICS 2020 11TH ST. LOS OSOS, CA 93402 US 805-528-6005 / 805-528-6005 |
FIBRIN (OGEN) FDP CONTROL | MULTI-LEVEL FIBRINOGEN FDP CONTROLS |
| 17 | REMEL EUROPE LTD REMEL HOUSE, CLIPPER BLVD. WEST CROSSWAYS DARTFORD, KENT, DA2 6PT UK 412-490-8425 / 412-490-8425 |
MULTIPLE | FIBRIN/FIBRINOGEN DEGRADATION PRODUCTS |
| 18 | SHIMA LABORATORIES CO., LTD. 1-16-4, MAENO-CHO ITABASHI-KU, TOKYO, 1740063 JA / 81-3-3967 7279 |
QA LATEX SHIMA (D-DIMER) | D-DIMER ASSAY & CALIBRATOR |
| 19 | STAGO R & D 125 AVE. LOUIS ROCHE GENNEVILLIERS, 92230 FR 33-146-88 20 20 / 33-146-854851 |
ANTI-FDP E | FRANMENT E ANTISERUM |
| 20 | TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800 |
MDA D-DIMER | MDA D-DIMER |
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