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ENZYNUM-TEST, LH
 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 | CH - Clinical Chemistry |
| FDA Product Code | CEP |
| FDA Classification Name | RADIOIMMUNOASSAY, LUTEINIZING HORMONE |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 862.1485 |
| FDA Common Generic Name | ENZYNUM-TEST, LH |
| FDA Proprietary Device Name | ENZYNUM-TEST, LH |
| 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 MR - Remanufacturer RR - Repackager/Relabeller |
| FDA Listing Date | 05-26-94 |
| 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 | ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471 |
MULTIPLE: ARCHITECT, AXSYM, IMXLH | VARIOUS LH OR LUTEINIZING HORMONE ASSAYS |
| 2 | ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471 |
MULTIPLE: ARCHITECT, AXSYM, IMXLH | VARIOUS LH OR LUTEINIZING HORMONE ASSAYS |
| 3 | ABBOTT SMITH LABS, LLC 1485 N. PARK DR. WESTON, FL 33326 US 954-762-6000 / 954-762-6000 |
OVULITE | LUTEINIZING HORMONE TEST SYSTEM |
| 4 | ABON BIOPHARM (HANGZHOU) CO., LTD. HANGZHOU ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA HANGZHOU, ZHEJIANG, 310018 CH 781-674-3900 / 858-200-8972 |
ACON LH ONE STEP OVULATION TEST STRIP/DEVICE(URINE) | OVULATION TEST |
| 5 | ACCESS BIO INCORPORATE 2033 RT. 130 UNIT H MONMOUTH JUNCTION, NJ 08852 US 732-297-2222 / 732-297-2222 103 |
Q SIGN | OVULATION TEST KIT |
| 6 | ACON BIOTECH (HANGZHOU) CO., LTD. 398 TIANMUSHAN RD. GUDANG INDUSTRIAL PARK HANGZHOU, P.R., 310023 CH 86-571-03963569 / 858-875-8000 1828 |
ACON LH ONE STEP OVULATION TEST STRIP/DEVICE (URINE) | OVULATION TEST |
| 7 | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US 858-535-2030 / 858-875-8000 1828 |
ACON LH ONE STEP OVULATION TEST STRIP / DEVICE, URINE | OVULATION TEST |
| 8 | ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. POWAY, CA 92064 US 858-513-3888 / 858-513-3888 314 |
MULTIPLE | VARIOUS |
| 9 | AMERITEK USA, INC. 125 130 ST. SE, #200 EVERETT, WA 98208 US 425-379-2580 / 425-379-2580 |
DBEST LH TEST KIT | LH TEST KIT |
| 10 | APPLIED BIOTECH 10237 FLANDERS CT. SAN DIEGO, CA 92121 US 781-674-3900 / 858-587-6771 |
SURESTEP OVULATION PREDICTOR | LH TEST |
| 11 | BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | VARIOUS |
| 12 | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383 |
ACCESS HLH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | HLH EIA (ENZYME IMMUNOASSAY) |
| 13 | BERKLEY INDUSTRIES, LLC 14450 INDUSTRY CIR. LA MIRADA, CA 90638 US 714-670-4274 / 714-522-5400 4274 |
OVUQUICK ONE-STEP OVULATION PREDICTOR | IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN LUTEINIZING HORMONE IN URINE |
| 14 | BIOCHECK, INC. 323 VINTAGE PARK DR. FOSTER CITY, CA 94404 US / 650-573-1968 |
BIOCHECK LH EIA TEST KIT | LUTEINZING HORMONE EIA TEST KIT |
| 15 | BIOMERICA, INC. 1533 MONROVIA AVE. NEWPORT BEACH, CA 92663 US 949-645-2111 / 949-645-2111 330 |
FORTEL OVULATION 11500 | HOME OVULATION TEST URINE |
| 16 | BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594 |
VIDAS LUTEINIZING HORMONE ASSAY | ELFA FOR QUANTITATIVE DETECTION OF HUMAN LH |
| 17 | BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594 |
VIDAS LUTEINIZING HORMONE ASSAY | ELFA FOR QUANTITATIVE DETECTION OF HUMAN LH |
| 18 | BIOTECH ATLANTIC, INC. BAY F, 6 INDUSTRIAL WAY WEST EATONTOWN, NJ 07724 US 732-389-4789 / 732-389-4789 |
UNIMARK OVULATION PREDICTOR | OVULATION PREDICTOR |
| 19 | BRISAR INDUSTRIES, INC 150 E. 7TH ST. PATERSON, NJ 07524 US 973-278-2500 / 973-278-2500 2242 |
MULTIPLE OVULATION TEST | OVULATION TEST |
| 20 | BTNX, INC. 570 HOOD ROAD, UNIT 23 MARKHAM, L3R 4G7 CA 905-944-9565 / 303-234-9412 |
BIOTECHNOSTIX | LUTEINIZING HORMONE TEST SYSTEM |
| 21 | CALBIOTECH, INC. 10461 AUSTIN DR., #G SPRING VALLEY, CA 91978 US 619-660-6162 / 619-660-6162 |
ELISA LH (EASY ELISA LH) | LUTEINIZING HORMONE (LH) ELISA |
| 22 | CHEMBIO DIAGNOSTIC SYSTEMS, INC. 3661 HORSEBLOCK RD. MEDFORD, NY 11763 US 631-924-1135 / 631-924-1135 |
MULTIPLE | IMMUNOCHROMOTOGRAPHIC ASSAY FOR VISUAL DETECTION OF LUTEINIZING HORMONE |
| 23 | CTK BIOTECH, INC. 6748 NANCY RIDGE DR. SAN DIEGO, CA 92121 US 858-457-8698 / 858-457-8698 |
LH DETECT ELISA KIT | LH ELISA KIT |
| 24 | DELVCO PHARMA PACKAGING SERVICES, INC 1200 ERIE AVE. PHILADELPHIA, PA 19124 US 973-278-2500 / 973-278-2500 |
MULTIPLE OVULATION TEST | OVULATION TEST |
| 25 | DIAGNOSTICS BIOCHEM CANADA, INC. 1020 HARGRIEVE RD. LONDON, ONTARIO, N6E 1P5 CA 519-681-8731 / 519-681-8731 |
LUTEINIZING HORMONE BY ENZYME IMMUNOASSAY (EIA) | LUTEINIZING HORMONE ENZYME IMMUNOASSAY TEST SYSTEM |
| 26 | DRG INSTRUMENTS GMBH FRAUENBERGSTRASSE 18 MARBURG, D-35039 GM 908-233-2079 / 908-233-2079 |
LUTEINIZING HORMONE TEST SYSTEM | LH |
| 27 | DRG INTL., INC. 1167 US HIGHWAY 22 MOUNTAINSIDE, NJ 07092 US 908-233-2079 / 908-233-2075 |
DRG AURICA LH ELISA TEST- SERUM AND URINE | LH ELISA KIT, EIA1289 (SERUM) AND EIA1290 (URINE) |
| 28 | DYN-BIOSHAF (2006) LTD. 7 HA'ESHEL ST. CAESAREA INDUSTRIAL PARK, 38900 IS 972-4-8202056 / 603-369-3550 |
FLOW-LH | LUTEINIZING HORMONE TEST SYSTEM |
| 29 | EARLY DETECT, INC. 2950 NORTH GLASSELL ST. ORANGE, CA 92865 US 714-283-5190 / 714-283-5190 |
KNOW NOW OVULATION WOND | FOR THE DETERMINATION LH IN URINE |
| 30 | FERTILFACIL SL AV DE LOS TRABAJADORES PARCELA 24-25 POL IND LOS VASALOS ONIL, ALICANTE, 03430 SP 34-96-5565903 / 34-96-5565903 |
EASY FERTILE | FERN TEST, SALIVA, OVULATION MICROSCOPE |
| 31 | GENUA 1944, INC. 185 COSBURN AVE. SUITE 102 TORONTO, ONTARIO, M4J 2L1 CA 416-466-2190 / 416-466-2190 |
MULTIPLE | VARIOUS |
| 32 | GERMAINE LABORATORIES, INC. 4139 GARDENDALE CENTER, SUITE 101 SAN ANTONIO, TX 78229 US 210-692-4192 / 210-692-4192 |
ACCUHOME & AIMSTEP | VARIOUS TYPES, OVULATION TEST |
| 33 | GLOBAL BUSINESS SUPPORT SYSTEMS, INC. 9520 CHESAPEAKE DRIVE, #601 SAN DIEGO, CA 92123 US 858-430-2800 / 858-430-2800 112 |
ACON LH ONE STEP OVULATION TEST,OVULITE | OVULATION TEST |
| 34 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
GLOBALEMED SMART CHECK LH OVULATION TEST STRIP/DEVICE, GLOBALEMED LH EIA | LH OVULATION TEST |
| 35 | 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 OVULATION MIDSTREAM TEST | OVULATION TEST |
| 36 | HEALTH CHECK PRODUCTS, INC. 6681 MAGNOLIA AVE., SUITE J RIVERSIDE, CA 92506 US 951-788-2400 / 951-325-7195 |
HEALTH CHECK OVULATION TEST | HEALTH CHECK OVULATION TEST |
| 37 | HERICHSON BIOMEDIX, INC. 1614 BRILL DR. FRIENDSWOOD, TX 77546 US 713-992-8288 / 713-992-8288 |
RADIOIMMUNOASSAY, LUTEINIZING HORMONE | LUTEINZING HORMONE EIA TEST KIT |
| 38 | IBL GMBH FLUGHAFENSTRASSE, 52A HAMBURG, D-22335 GM 49-40-53289122 / 715-294-1752 |
IBL LEUTINIZING HORMONE TEST SYSTEM | IBL LEUTINIZING HORMONE TEST SYSTEM |
| 39 | IMMUNALYSIS CORPORATION 829 TOWNE CENTER DR. POMONA, CA 91767 US 909-482-0840 / 909-482-0840 |
LUTEINIZING HORMONE DIRECT RIA KIT (125I) | RIA METHOD TO DETERMINE LUTEINIZING HORMONE IN SERUM |
| 40 | IND DIAGNOSTIC INC. 1629 FOSTERS WAY DELTA, BC, V3M 6S7 CA 604-522-1619 / 604-522-1619 |
ONE STEP LH OVULATION TEST | LH OVULATION TEST KIT |
| 41 | INNOVACON, INC. 4106 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US 781-674-3900 / 858-200-8972 |
ACON LH ONE STEP OVULATION TEST STRIP,TEST DEVICE (URINE) | OVULATION TEST |
| 42 | INVERNESS MEDICAL (SHANGHAI) CO., LTD. NO. 151 LIBING ROAD SHANGHAI, 201203 CH 781-674-3900 / 86-21-51320505 |
MULTIPLE | OVULATION PREDICTOR HOME TEST |
| 43 | INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-SAN DIE 4106 SORRENTO VALLEY BOULEVARD SAN DIEGO, CA 92121 US 781-674-3900 / 858-200-8972 |
ACON LH ONE STEP OVULATION TEST STRIP/TEST DEVICE (URINE) | OVULATION TEST |
| 44 | INVERNESS MEDICAL, INC. 569 HALLS MILL RD FREEHOLD, NJ 07728 US 781-674-3900 / 732-625-7278 |
EARLY OVULATION PREDICTOR, ONE-STEP OVULATION PREDICTOR | OVULATION PREDICTOR TEST |
| 45 | JANT PHARMACAL CORP. 16255 VENTURA BLVD., SUITE 505 ENCINO, CA 91436 US 818-986-8530 / 818-986-8530 |
ACCUTEST LH OVULATION TEST | TEST FOR LH IN HUMAN URINE |
| 46 | L. PERRIGO CO. 515 EASTERN AVE. ALLEGAN, MI 49010 US 269-673-9228 / 269-673-9228 |
MULTIPLE | OVULATION TEST |
| 47 | LAKE CONSUMER PRODUCTS, INC. N 168 W22223 MAIN ST. JACKSON, WI 53037 US 262-677-4121 / 262-677-4121 7110 |
BABY START OVULATION TEST | OVULATION TEST |
| 48 | LUNA FERTILITY INDICATOR, INC. 1411 WELLINGTON CRESCENT RICHMOND B.C., V7B 1G6 CA 604-244-0056 / 360-379-3660 |
LUNA FERTILITY INDICATOR | OVULATION PREDICTION DEVICE |
| 49 | MONOBIND, INC. 100 N. POINTE DR. LAKE FOREST, CA 92630 US 949-951-2665 / 949-951-2665 |
LUTEINIZING HORMONE MICROPLATE ELISA | LH ELISA |
| 50 | MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285 |
MULTIPLE | PROCEDURE FOR THE RIA OF HUMAN SERUM LUTENIZING HORMONE |
| 51 | NEW CREATION TECHNOLOGY LTD. RM 2401 HK WORSTED MILLS IND. BLDG., 31-39 WO TONG TSUI ST. KWAI CHUNG, NT, HK 847-837-3405 / 852-248-04458 |
OVULATION SCOPE | SALIVA OVULATION TEST |
| 52 | NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD NO.65, 6TH AVE, TEDA TIANJIN, 300457 CH 86-22-25321648 / 86-22-25321648 |
LH RAPID TEST STRIP, CASSETTE, MIDSTREAM | OVULATION DETECTION TEST |
| 53 | NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO SAN CLEMENTE, CA 92673 US 949-940-7200 / 949-940-7465 |
MULTIPLE | MULTIPLE |
| 54 | ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152 |
KODAK AMERLITE LH-30 ASSAY (LAN.0082/2082) | LUTEINIZING HORMONE TEST SYSTEM NRIA |
| 55 | PERRIGO DE MEXICO 3089 AV. INDUSTRIA AUTOMOTRIZ RAMOA ARIZPE, COAHUILA, 25900 MX 269-673-9228 / 269-686-7219 |
MULTIPLE | OVULATION TEST |
| 56 | PHAMATECH INC. 10151 BARNES CANYON RD SAN DIEGO, CA 92121 US 858-643-5555 / 858-643-5555 231 |
OVUCARD LH TEST | OVULATION TEST |
| 57 | PILOT INDUSTRIES 46 CANAL ST. ELLENVILLE, NY 12428 US 845-331-4300 287 / 845-647-7711 |
FIRST TEST OVULATION PREDICTOR | OVULATIOIN PREDICTOR TEST |
| 58 | RAPID DIAGNOSTICS 1429 ROLLINS RD. BURLINGAME, CA 94010 US 949-833-2500 / 949-833-2500 |
RAPID LH OVULATION TEST | LH TEST |
| 59 | ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834 |
ELECSYS LH ASSAY | ELECTROCHEMILUMINESCENCE ASSAY FOR DETERMINATION OF HUMAN LUTEINIZING HORMONE |
| 60 | ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834 |
ELECSYS LH ASSAY | LUTEINIZING HORMONE ASSAY |
| 61 | RUNBIO BIOTECH CO., LTD. RONGSHONG TECHNOLOGICAL ZONE UNIVERSITY ROAD, SHANTOU GUANGDONG, 515063 CH 86-754-2537812 / 310-532-0009 |
DAVID OVULATION TEST (MIDSTREAM), DAVID OVULATION TEST (STRIP) | OVULATION, LH, TEST, KIT, STRIP, MIDSTREAM OTC AND/OR PRESCRIPTION USE |
| 62 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955 |
RIA, IMMULITE, IML 1000, IML 2000, IML 2500 LH | IMMUNOMETRIC ASSAY FOR MEASUREMENT OF (LH, LUTROPIN) LH |
| 63 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540 |
MAGIC LITE LH LUTENIZING HORMONE ASSAY | IMMUNOASSAY |
| 64 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955 |
CAC IRMA, IMMULITE, IML 1000, IML 2000, IML 2500 LH | IMMUNOMETRIC ASSAY FOR MEASUREMENT OF (LH, LUTROPIN) LH |
| 65 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955 |
RIA, IMMULITE, IML 1000, IML 2000, IML 2500 LH | IMMUNOMETRIC ASSAY FOR MEASUREMENT OF (LH, LUTROPIN) LH |
| 66 | SPD SWISS PRECISION DIAGNOSTICS GMBH C/O PROCTER & GAMBLE 47 ROUTE DE SAINT-GEORGES PETIT-LANCY, GENEVA, CH-1213 SZ 41-58-0045032 / 44-123-4835564 |
MULTIPLE | OVER THE COUNTER OVULATION TEST KIT |
| 67 | ST. PAUL BIOTECH 11555 MONARCH ST. GARDEN GROVE, CA 92841 US 714-903-1000 / 714-903-1000 226 |
NUGEN BIOTECH OVULATION TEST | OVULATION TEST |
| 68 | SYNTRON BIORESEARCH, INC. 2774 LOKER AVE. WEST CARLSBAD, CA 92010 US 760-930-2200 / 760-930-2200 223 |
MULTIPLE | OVULATION TEST |
| 69 | 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 | OVULATION TESTS |
| 70 | TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909 |
AIA-PACK LH II, ST AIA-PACK LH II | LUTEINIZING HORMONE TEST SYSTEM |
| 71 | TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909 |
AIA-PACK LH II, ST AIA-PACK LH II | LUTEINIZING HORMONE TEST SYSTEM |
| 72 | TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909 |
AIA-PACK LH II, ST AIA-PACK LH II | LUTEINIZING HORMONE TEST SYSTEM |
| 73 | TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909 |
AIA-PACK LH | LUTEINIZING HORMONE TEST SYSTEM |
| 74 | UNIPATH LTD. PRIORY BUSINESS PARK BEDFORD, MK44 3UP UK 781-674-3900 / 441-234-835564 |
MULTIPLE | VARIOUS |
| 75 | UNITED BIOTECH, INC. 211 S. WHISMAN ROAD, SUITE E MOUNTAIN VIEW, CA 94041 US 650-961-2910 / 650-961-2910 |
UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE | LUTEINIZING HORMONE(LH) |
| 76 | WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111 |
AUTO DELFIA HLH SPEC KIT | FLUOROIMMUNOASSAY FOR THE DETERMINATION OF LUTEINIZING HORMONE |
| 77 | ZENTEK INTERNATIONAL INC 3 FL, ASIA B/D 688-4 YUKSAM-DONG KANGMAN-KU, SEOUL, 135-917 KS / 02-563-2221 |
LADY FREE BIOTESTER | SALIVA FERTILITY TESTER |
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