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CEDIA DAU PCP ASSAY
 Request for Information Form |
 Contact Information
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| Company Name | MICROGENICS CORPORATION |
| Address | 44560-44660 OSGOOD RD |
| City, State, Zip | FREMONT, CA 94539 |
| Country | US |
| FDA Owner/Operator Phone | 412-490-8425 |
| FDA Medical Specialty Code | TX - Clinical Toxicology |
| FDA Product Code | LCM |
| FDA Classification Name | ENZYME IMMUNOASSAY, PHENCYCLIDINE |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 862.3100 |
| FDA Common Generic Name | HOMOGENEOUS ENZYME IMMUNOASSAY |
| FDA Proprietary Device Name | CEDIA DAU PCP ASSAY |
| FDA Owner / Operator Number | 2517925 |
| FDA Owner / Operator Name | FISHER SCIENTIFIC CO., LLC. |
| FDA Establishment Registration Number | 3005304572 |
| FDA Registered Establishment Name | MICROGENICS CORPORATION |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 07-22-05 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of MICROGENICS CORPORATION
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 |
MULTIPLE | PCP |
| 2 | ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471 |
MULTIPLE | PCP |
| 3 | ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471 |
MULTIPLE | PCP |
| 4 | ABON BIOPHARM (HANGZHOU) CO., LTD. HANGZHOU ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA HANGZHOU, ZHEJIANG, 310018 CH 781-674-3900 / 858-200-8972 |
ACON PCP ONE STEP PHENCYCLIDINE TEST STRIP/DEVICE | PCP DRUG OF ABUSE TEST |
| 5 | ACON BIOTECH (HANGZHOU) CO., LTD. 398 TIANMUSHAN RD. GUDANG INDUSTRIAL PARK HANGZHOU, P.R., 310023 CH 86-571-03963569 / 858-875-8000 1828 |
ACON PCP ONE STEP PHENCYCLIDINE TEST STRIP/DEVICE | PCP DRUG OF ABUSE TEST |
| 6 | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US 858-535-2030 / 858-875-8000 1828 |
ACON PCP ONE STEP PHENCYCLIDINE TEST STRIP / DEVICE | PCP DRUG OF ABUSE TEST |
| 7 | ACRO BIOTECH LLC. 9500 7TH STREET UNIT M RANCHO CUCAMONGA, CA 91730 US 909-466-6892 / 909-466-6892 |
CARDLAB,QUICKCUP,CUPLAB | POINT OF CARE RAPID TEST |
| 8 | AKERS BIOSCIENCES, INC. 201 GROVE RD. THOROFARE, NJ 08086 US 856-848-8698 / 856-848-8698 |
HEALTH TEST ONE STEP | PHENCYCLIDINE-DRUG OF ABUSE TEST |
| 9 | ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. POWAY, CA 92064 US 858-513-3888 / 858-513-3888 314 |
NSTANT-VIEW PHENCYCLIDINE (PCP) URINE TEST | PHENCYCLIDINE (PCP) URINE TEST |
| 10 | AMEDICA BIOTECH, INC. 28301 INDUSTRIAL BLVD SUITE K HAYWARD, CA 94545 US 510-785-5980 / 510-785-5980 |
AMEDICA DRUG SCREEN PCP TEST | DRUG SCREEN PCP TEST |
| 11 | AMEDITECH, INC. 10340 CAMINO SANTA FE SUITE F SAN DIEGO, CA 92121 US 858-535-1968 / 858-535-1968 |
IMMUTEST DRUG SCREEN PCP | VARIOUS |
| 12 | AMERICAN BIO MEDICA CORP. 122 SMITH RD. KINDERHOOK, NY 12106 US 518-758-8158 / 856-241-2320 |
RAPID DRUG SCREEN | ONE STEP LATERAL FLOW IMMUNOASSAY |
| 13 | AMERICAN BIO MEDICA CORP. 603 HERON DR. UNIT 3 LOGAN TOWNSHIP, NJ 08085 US 518-758-8158 / 856-241-2320 |
RAPID DRUG SCREEN | ONE STEP LATERAL FLOW IMMUNOASSAY |
| 14 | APPLIED BIOTECH 10237 FLANDERS CT. SAN DIEGO, CA 92121 US 781-674-3900 / 858-587-6771 |
SURESTEP DRUG SCREEN PCP TEST | PCP TEST |
| 15 | BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | PHENCYCLIDINE ENZYME IMMUNOASSAY |
| 16 | BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383 |
MULTIPLE | PHENCYCLIDINE ENZYME IMMUNOASSAY |
| 17 | BIOMERICA, INC. 1533 MONROVIA AVE. NEWPORT BEACH, CA 92663 US 949-645-2111 / 949-645-2111 330 |
ONE STEP PHENCYCLIDINE TEST | PHENCYCLIDINE TEST KIT |
| 18 | BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US 781-674-3900 / 858-805-3423 |
TRIAGE TOX DRUG SCREEN | FLUORESCENCE IMMUNOASSAY FOR DETECTION OF DRUGS OF ABUSE IN URINE |
| 19 | BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E IRVINE, CA 92618 US 949-598-7166 / 949-598-7166 113 |
MONITECT PCP DRUG SCREEN TEST | IMMUNOCHROMATOGRAPHICAL TEST FOR QUALITATIVE DETERMINATION OF PCP IN HUMAM URINE |
| 20 | BTNX, INC. 570 HOOD ROAD, UNIT 23 MARKHAM, L3R 4G7 CA 905-944-9565 / 303-234-9412 |
BIOTECHNOSTIX | ENZYME IMMUNOASSAY,PHENCYCLIDINE |
| 21 | CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272 |
PHENCYCLIDINE | PHENCYCLIDINE REAGENT |
| 22 | CHINESE PEPTIDE COMPANY NO. 69, 12 STREET, ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, HANGZHOU, CH 86-571-86737118 / 408-392-0064 |
UCP RAPID PHENCYCLIDINE TEST | PHENCYCLIDINE TEST SYSTEM |
| 23 | DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311 |
MULTIPLE | ENZYME IMMUNOASSAY, PHENCYCLIDINE |
| 24 | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311 |
MULTIPLE | VARIOUS ACA URINE PHENCYCLIDINE (U PCP) SCREEN METHOD |
| 25 | DRUG DETECTION DEVICES, LTD. 6820 MEADOWRIDGE COURT SUITE A-7 ALPHARETTA, GA 30005 US 770-886-6226 / 888-768-6786 |
MULTIPLE DRUGSCREEN DIP PCP TEST/SCREENERS PCP TEST | PCP TEST |
| 26 | ESCREEN INC. 9886 PFLUMM LENEXA, KS 66215 US 913-327-5915 / 800-881-0722 2257 |
ESCREEN DRUGS OF ABUSE SCREENING SYSTEM | ESCREEN DRUGS OF ABUSE SCREENING SYSTEM |
| 27 | ESCREEN, INC. 7500 W. 110TH ST, STE 500 OVERLAND PARK, KS 66210 US 913-327-5915 / 913-327-5915 2257 |
ESCREEN DRUGS OF ABUSE SCREENING SYSTEM | ESCREEN DRUGS OF ABUSE SCREENING SYSTEM |
| 28 | ESCREEN, INC. 952 WEST MELINDA LN., SUITE B PHOENIX, AZ 85027 US 913-327-5915 / 800-881-0722 2257 |
ESCREEN DRUGS OF ABUSE SCREENING SYSTEM | ESCREEN DRUGS OF ABUSE SCREENING SYSTEM |
| 29 | EXPRESS DIAGNOSTICS INT'L, INC. 1550 INDUSTRIAL DR. BLUE EARTH, MN 56013 US 507-526-3951 / 507-526-3951 |
DRUGCHECK DRUGS OF ABUSE SCREENING TEST | DRUGS OF ABUSE SCREENING TEST |
| 30 | FAST GUARD MEDICAL REAGENT COMPANY LTD. 8TH BUILDING, NO. 200 MIDDLE SUHONG ROAD SUZHOU, JIANGSU, 215021 CH 86-512-62588605 / 949-598-7166 111 |
FASTECT II PCP DRUG SCREEN DIPSTICK TEST | IMMUNOCHROMATOGRAPHICAL TEST FOR THE QUALITATIVE DETEMINATION OF PCP IN HUMAN UR |
| 31 | GERMAINE LABORATORIES, INC. 4139 GARDENDALE CENTER, SUITE 101 SAN ANTONIO, TX 78229 US 210-692-4192 / 210-692-4192 |
AIMSCREEN, & MULTIDRUG | VARIOUS TYPES, PHENCYCLIDINE TESTS |
| 32 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
GLOBALEMED SMART CHECK PHENCYCLIDINE TEST STRIP/DEVICE | PHENCYCLIDINE DRUG OF ABUSE TEST |
| 33 | GUANGZHOU WONDFO BIOTECH CO., LTD. WONDFO SCIENTECH PARK, SOUTH CHINA UNIV. OF TECHNOLOGY GUANGZHOU, GUANGDONG, 510641 CH 86-20-87111194 / 215-369-3705 |
ONE STEP DRUGS OF ABUSE | PHENCYCLIDINE DRUG OF ABUSE ASSAY |
| 34 | GUARDIAN DIAGNOSTICS 679 EAST BROKAW RD. SAN JOSE, CA 95112 US 408-910-9340 / 408-910-9340 |
GUARDIAN RAPID PCP TEST | PHENCYCLIDINE TEST SYSTEM |
| 35 | INNOVACON, INC. 4106 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US 781-674-3900 / 858-200-8972 |
ACON PCP ONE STEP PHENCYCLIDINE TEST STRIP,TEST DEVICE | PCP DRUG OF ABUSE TEST |
| 36 | INNOVATIVE MEDICAL TECHNOLOGIES 1532-A BORI ST, URB. BELISA RIO PIEDRAS, PR 00927 US 787-753-4009 / 787-753-4009 |
EXCEL PCP ONE STEP PHENCYCLIDINE TEST STRIP, TEST DEVICE | PCP DRUG OF ABUSE TEST |
| 37 | INTEC PRODUCTS, INC. (XIAMEN) 332 XINGUANG ROAD XINYANG IND. AREA, HAICANG XIAMEN FUJIAN, 361022 CH 059-268-07188 / 86-592-6807188 |
ADVANCED QUALITY(TM) PHENYLCYCLIDINE(PCP)TEST | PCP TEST |
| 38 | JANT PHARMACAL CORP. 16255 VENTURA BLVD., SUITE 505 ENCINO, CA 91436 US 818-986-8530 / 818-986-8530 |
ACCUTEST PCP DRUG SCREEN | TEST TO DETECT PHENCYCLIDINE IN HUMAN URINE |
| 39 | KACEY MED-VET, INC. 60 MCCORMICK PL. ASHEVILLE, NC 28801 US 828-258-1482 / 828-258-1482 |
KACEY DRUG SCREEN TEST PHENCYCLIDINE | PCP |
| 40 | LIN-ZHI INTERNATIONAL, INC. 687 NORTH PASTORIA AVE. SUNNYVALE, CA 94085 US 408-732-3856 / 408-732-3856 |
ENZYME IMMUNOASSAY, PHENCYCLIDINE | HOMOGENEOUS ENZYME IMMUNOASSAY FOR THE DETERMINATION OF PHENCYCLIDIN IN URINE |
| 41 | LUSYS LABORATORIES INC. 10054 MESA RIDGE COURT SUITE 118 SAN DIEGO, CA 92121 US 858-546-0902 / 858-546-0902 |
QIKTECH DOB 5-PANEL | ENZYME IMMUNOASSAY FOR AMP, BZD, COC, OPI, THC |
| 42 | MEDTOX DIAGNOSTICS, INC. 1640 NOVA LANE BURLINGTON, NC 27215 US 800-334-1116 / 800-334-1116 |
VERDICT-II PCP, PROFILE-II, PROFILE-II ER, AND SURE-SCREEN | IMMUNOCHROMATOGRAPHIC ASSAY FOR PHENCYCLIDINE (PCP) |
| 43 | MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. BURLINGTON, NC 27215 US 800-334-1116 / 800-334-1116 235 |
VERDICT-II PCP, PROFILE-II, PROFILE-II ER, AND SURE-SCREEN | IMMUNOCHROMATOGRAPHIC ASSAY FOR PHENCYCLIDINE (PCP) |
| 44 | MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425 |
CEDIA DAU PCP ASSAY | HOMOGENOUS ENZYME IMMUNOASSAY |
| 45 | MIRAKONE, INC. 679 EAST BROKAW RD. SAN JOSE, CA 95112 US 408-234-1368 / 408-234-1368 |
RAPID PHENCYCLIDINE TEST | PHENCYCLIDINE TEST SYSTEM |
| 46 | NANO-DITECH CORPORATION 11 DEER PARK DRIVE SUITE 118 MONMOUTH JUNCTION, NJ 08852 US 732-438-8616 / 732-438-8616 |
NANO-CHECK DAT 5 MULTI SCREENING TEST ET AL, VARIOUS NAMES AND MODELS | ENZYME IMMUNOASSAY, PHENCYCLIDINE |
| 47 | ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. BETHLEHEM, PA 18018 US 610-882-1820 / 610-882-1820 5043 |
ENZYME IMMUNOASSAY, PHENCYCLIDINE (MULTIPLE BRANDS) | VARIOUS TYPES OF PCP EIAS |
| 48 | ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768 |
VITROS CHEMISTRY PRODUCTS PCP REAGENT | PHENCYCLIDINE TEST SYSTEM |
| 49 | PAN PROBE BIOTECH, INC. 7396 TRADE ST. SAN DIEGO, CA 92121 US 858-689-9936 / 858-232-3493 |
PHENCYCLIDINE RAPID TEST DEVICE | DETERMINATION OF PHENCYCLIDINE IN HUMAN URINE |
| 50 | PHAMATECH INC. 10151 BARNES CANYON RD SAN DIEGO, CA 92121 US 858-643-5555 / 858-643-5555 231 |
QUICKSCREEN ONE STEP PHENCYCLIDINE SCREENING TEST | PCP RAPID TEST |
| 51 | PILOT INDUSTRIES 46 CANAL ST. ELLENVILLE, NY 12428 US 845-331-4300 287 / 845-647-7711 |
ACON PCP ONE STEP PHENCYCLIDINE STRIP AND ACON PCP ONE STEP PHENCYCLIDINE TEST D | IMMUNOCHROMATOGRAPHIC TEST FOR QUALITATIVE DETECTION OF PHENCYCLIDINE IN URINE S |
| 52 | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 MONMOUTH JUNCTION, NJ 08852 US 732-274-1000 / 732-274-1000 |
ACCUSIGN PCP | RAPID ONE STEP PHENCYCLIDINE ASSAY |
| 53 | QUANTRX BIOMEDICAL CORPORATION 5920 NE 112TH AVE. PORTLAND, OR 97220 US 267-880-1595 / 503-252-9565 |
ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS | DRUGS OF ABUSE SCREENING TEST |
| 54 | RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413 |
RANDOX PHENCYCLIDINE ASSAY | PHENCYCLIDINE ASSAY |
| 55 | RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413 |
RANDOX PHENCYCLIDINE ASSAY | PHENCYCLIDINE ASSAY |
| 56 | RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413 |
RANDOX PHENCYCLIDINE ASSAY | PHENCYCLIDINE ASSAY |
| 57 | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413 |
RANDOX PHENCYCLIDINE ASSAY | PHENCYCLIDINE ASSAY |
| 58 | RAPID DIAGNOSTICS 1429 ROLLINS RD. BURLINGAME, CA 94010 US 949-833-2500 / 949-833-2500 |
FOB TEST | FECAL OCCULT BLOOD TEST |
| 59 | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834 |
ONTRAK TEST CUPS | VARIOUS |
| 60 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
ADVIA CHEMISTRY PHENCYCLIDINE TEST | PHENCYCLIDINE ASSAY |
| 61 | STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772 |
EZ-SCREEN MULTIDRUG-5PC INTEGRATED CUP | PCP DRUG OF ABUSE TEST |
| 62 | STARPLEX SCIENTIFIC, INC. 50-A STEINWAY BLVD. ETOBICOKE, ONTARIO, M9W 6Y3 CA 416-674-7474 / 416-674-7474 |
STARTOX (TM) DRUGS OF ABUSE SCREENING TEST | IMMUMOASSAY FOR THE SIMULTANEOUS DETECTION OF MULTIPLE DRUG ANALYTES IN URINE. |
| 63 | SUN BIOMEDICAL LABORATORIES, INC. 604 VPR CENTER 1001 LOWER LANDING RD. BLACKWOOD, NJ 08012 US 856-401-1080 / 856-401-1080 |
VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE TEST | DRUG TEST FOR PCP IN HUMAN URINE -QUALITATIVE |
| 64 | SYNTRON BIORESEARCH, INC. 2774 LOKER AVE. WEST CARLSBAD, CA 92010 US 760-930-2200 / 760-930-2200 223 |
MULTIPLE | PCP TEST |
| 65 | TIANJIN NEW BAY BIORESEARCH CO., LTD. 3 JIAN SHE ROAD, BA LI TAI INDUSTRY AREA, JIN NAN DISTRICT, TIANJIN, 300350 CH 86-22-28751515 / 760-602-2929 |
MULTIPLE | PHENCYCLIDINE TEST |
| 66 | UCP BIOSCIENCES, INC. 1445 KOLL CIRCLE, STE. 111 SAN JOSE, CA 95112 US 408-392-0064 / 408-392-0064 |
UCP RAPID PHENCYCLIDINE TEST | PHECYCLIDINE TEST SYSTEM |
| 67 | VARIAN INC 25200 COMMERCENTRE DR. LAKE FOREST, CA 92630 US 650-424-5078 / 949-639-5415 |
ON TRAK TEST CUP, VARIETY, MULTI-ANALYTE, ON TRAK TEST STIK | DRUG TESTING DEVICES |
| 68 | W.H.P.M. INC. NO.2 LOU ZI ZHUANG CENTRAL ST. CHAYANG DISTRICT BEIJING, 100018 CH 86-108-4391126 / 978-927-3808 |
FIRST SIGN DRUG OF ABUSE SCREENING TEST | DRUG OF ABUSE SCREENING |
| 69 | W.H.P.M., INC. 9662 TELSTAR AVE. EL MONTE, CA 91731 US 626-443-8480 / 978-927-3808 |
FIRST SIGN DRUG OF ABUSE SCREENING TEST | DRUG OF ABUSE SCREENING |
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