|
ON TRAK TESTCUP PRO-S
 Request for Information Form |
 Contact Information
|
| 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 | MI - Microbiology |
| FDA Product Code | JXA |
| FDA Classification Name | KIT, SCREENING, URINE |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 866.2660 |
| FDA Common Generic Name | QUALITATIVE DETECTION OF DRUGS METABOLITES IN URINE |
| FDA Proprietary Device Name | ON TRAK TESTCUP PRO-S |
| 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 |
| FDA Listing Date | 07-24-00 |
| 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 MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 US 847-937-6100 / 847-938-3471 |
MULTICOLLECT | SAMPLING, TRANSPORT AND STORAGE DEVICE |
| 2 | ANDWIN SCIENTIFIC 6636 VARIEL AVE. WOODLAND HILLS, CA 91303 US 818-999-2828 / 818-999-2828 270 |
BORITEX | URINE COLLECTION KIT |
| 3 | APO DIAGNOSTICS, INC. 50 STEINWAY BLVD. UNIT 3 ETOBICOKE (TORONTO) ONTARIO, M9W 6Y3 CA 416-798-8088 / 416-798-8088 |
URI-DIP | SEMI-QUANTATIVE CULTURE TEST FOR BACTERIA |
| 4 | BIOCHEMICAL DIAGNOSTIC, INC. 180 HEARTLAND BLVD. BRENTWOOD, NY 11717 US 631-595-9200 / 631-595-9200 |
KITS FOR URINE SCREENING ANALYSIS CONSISTING OF EXTRACTION COLUMNS | |
| 5 | BIOMERIEUX FRANCE 5 RUE DE ACQUEDUCS CRAPONNE, 69290 FR 33-478-872063 / 314-731-8594 |
CPS-ID2 | URINE SCREENING KIT |
| 6 | BIOTEX DIAGNOSTICS 148 8TH AVE., SUITE E LA PUENTE, CA 91746 US 626-333-4626 / 626-333-4626 |
BTD URINSTRIP 10 SL | REAGENT STRIPS FOR URINALYSIS |
| 7 | CLEAN-STREAM MEDICAL PRODUCTS, L.L.C. 500 SPARROW HAWK EDMOND, OK 73003 US 405-844-2099 / 405-844-2099 |
CLEAN-STREAM CATCH KIT | MIDSTREAM URINE KIT |
| 8 | CORAL BIOTECHNOLOGY 110 BOSSTICK BLVD. SAN MARCOS, CA 92069 US 760-727-8224 / 760-727-8224 |
UTISCREEN | UTISCREEN |
| 9 | CWS, INC. 17 MIDLAND DR. NORWICH, NY 13815 US 607-334-5366 / 607-334-5366 |
KIT, SCREENING, URINE | KIT, SCREENING, URINE |
| 10 | DIAGNOSTIC TEST GROUP, LLC 141 N.W. 20TH ST., SUITE F-2 BOCA RATON, FL 33431 US 561-347-5760 / 561-347-5760 |
KIT, SCREENING, URINE#MICROBIOLOGY | MULTISTRIP UROCHECK 10 SG / MULTISTRIP PREGCHECK |
| 11 | E.M. ADAMS CO., INC. 7496 COMMERCIAL CIRCLE FORT PIERCE, FL 34951 US 772-461-0532 / 772-461-0532 |
ADAMS KIDNEY STONE FILTERS | KIDNEY STONE FILTERS |
| 12 | EIKEN CHEMICAL CO., LTD. 1-33-8, HONGO BUNKYO-KU, TOKYO, 113-8408 JA 81-33-8134888 / 81-33-8134888 |
UROPAPER "EIKEN" GK | VARIOUS URINE TESTING KITS |
| 13 | ELITECH FRANCE SAS PARC D'ACTIVITES ALLEE D'ATHENES SIGNES, 83870 FR 33-4-90175450 / 435-752-6011 |
SCREEN GEL URI, URICHROM | KIT FOR DETECTION OF UROGENITAL BACTERIA |
| 14 | GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 US 858-410-8000 / 858-410-8891 |
GEN-PROBE PACE SYSTEM URINE SCREENING | FLASHTRACK SYSTEM FOR URINE SCREENING |
| 15 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
GLOBALEMED URINE REAGENT STRIP-SPECIFIC GRAVITY TEST | URINE REAGENT STRIP-SPECIFIC GRAVITY TEST |
| 16 | HIGH TECH LABS P.Z. HTL DANISZEWSKA 4 WARSZAWA, 03-230 PL |
COMBI STRIPS | URINE ANALYSIS STRIPS (URINE DIPSTICKS) |
| 17 | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. GARDEN GROVE, CA 92841 US 714-933-3107 / 714-933-3107 |
KO-LEC-PAC KIT | URINE SCREENING KIT |
| 18 | IRIS DEUTSCHLAND GMBH EMIL VON BEHRING STRASSE 35041 MARBURG, HESSEN, GM 818-709-1244 7129 / 818-709-1244 7129 |
QUICKVUE URINCHEK | URINE TEST STRIP FOR QUALITATIVE MEASUREMENT OF SELECTED ANALYTES IN URINE |
| 19 | LAPROL SCIENTIFIC, INC. 4890 SW 74TH CT. MIAMI, FL 33155 US 305-669-0898 / 305-669-0898 |
GLUCOSE, 3, URI-TEST 3 & 9 | REAGENT STRIP FOR URINALYSIS |
| 20 | LYNN PEAVEY CO. 14865 WEST 105TH ST. LENEXA, KS 66215 US 913-888-0600 / 800-255-6499 152 |
PEAVEY URINE TESTING KIT | PEAVEY URINE TESTING KIT |
| 21 | MARINE PRODUCTS TECH CO. 222 SICOX TOWER 513-14 SANGDAEWON-DONG, JUNGWON-GU SEONGNAM, KYUNGGI-DO, 462-705 KS 82-31-7779588 / 763-428-0010 |
KIT, SCREENING, URINE | URINE SCREENING KIT |
| 22 | MAST GROUP LTD. MAST HOUSE, DERBY RD. BOOTLE, MERSEYSIDE, L20 1EA UK / 441-519-33727 |
BACTERURITEST | TEST STRIPS FOR BACTERURIA |
| 23 | MATRITECH, INC. 330 NEVADA ST., 2ND FL. NEWTON, MA 02460 US 617-928-0820 / 617-658-5246 |
MATRITECH NMP22 TEST KIT | ENZYME IMMUNOASSAY FOR DETECTION OF NMP22 |
| 24 | MEDICAL CHEMICAL CORP. 19430 VAN NESS AVE TORRANCE, CA 90501 US 310-787-6800 / 310-787-6800 235 |
URINARY SEDIMENT STAIN SET | URINARY SEDIMENT STAIN SET |
| 25 | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229 |
KIT, SCREENING, URINE | FILTRACHECK UTI |
| 26 | NEW HORIZONS DIAGNOSTICS CORP. 9110 RED BRANCH RD., STE. B COLUMBIA, MD 21045 US 410-992-9357 / 410-992-9357 222 |
RAPID BACTIURIA SCREEN | RAPID BIOLUMINESCENCE BASED BACTIURIA SCREENING ASSAY |
| 27 | NOVAMED LTD. 28 PIERRE KOENIG ST., TALPIOT INDUSTRIAL AREA JERUSALEM, 93469 IS 972-267-81861 / 972-267-1861X111 |
DIASLIDE URINE CULTURING DEVICE | ONSITE URINE CULTURE DEVICE (DIASLIDE) |
| 28 | ORAL BIOTECH 812 WATER ST. NE ALBANY, OR 97321 US 541-928-4445 / 541-928-4445 |
CARISCREEN ATP BACTERIAL TEST | ATP BACTERIAL TEST |
| 29 | OXOID, LTD. WADE RD. BASINGSTOKE, HAMPSHIRE, RG24 8PW UK 603-929-2650 / 412-490-8425 |
OXOID DIP-SLIDES | DIP-SLIDES |
| 30 | QUALICUM SCIENTIFIC LTD. 15 CAPELLA CT, UNIT 8 OTTAWA, ONTARIO, K2E 7X1 CA 613-225-2444 / 613-225-2444 |
SOLAR-CULT | VARIOUS TYPES OF DIPCHEX |
| 31 | QUELAB LABORATORIES, INC. 2331 RUE DANDURAND ST. MONTREAL, QUEBEC, H2G 3C5 CA 514-277-2558 / 410-388-0070 |
MULTIPLE | VARIOUS TYPES OF URINE SCREENING DEVICES |
| 32 | QUIDEL CORP. 10165 MCKELLAR CT. SAN DIEGO, CA 92121 US 858-552-1100 / 858-552-1100 7910 |
MULTIPLE | VARIOUS |
| 33 | SAVYON DIAGNOSTICS, LTD. 3 HABOSEM ST. ASHDOD, 77610 IS 972-885-62920 / 972-885-62920x242 |
DIASLIDE CULTURING DEVICE | URINE CULTURING DEVICE |
| 34 | SAVYON DIAGNOSTICS, LTD. 3 HABOSEM ST. ASHDOD, 77101 IS 972-885-62920 / 972-885-62920 x242 |
MULTIPLE | VARIOUS |
| 35 | STARPLEX SCIENTIFIC, INC. 50-A STEINWAY BLVD. ETOBICOKE, ONTARIO, M9W 6Y3 CA 416-674-7474 / 416-674-7474 |
DIP N COUNT | STERILE SEMI-QUANTITATIVE CULTURE TEST FOR DETECTION OF URINARY TRACT INFECTION |
| 36 | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788 |
URINE REAGENT STRIP-SPECIFIC GRAVITY | URINE REAGENT STRIP-SPECIFIC GRAVITY |
| 37 | TRI-TECH, INC. 4019 EXECUTIVE PARK BLVD.,S.E. SOUTHPORT, NC 28461 US 910-457-6600 / 910-457-6600 |
KIT, SCREENING, URINE | TRI-TECH CUSTOM BLOOD AND,OR URINE TRANSPORT KIT |
[ Lab Equipment Categories ]
Copyright © 2000-2009
All Rights Reserved - Patent Pending
