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H. PYLORI TEST KIT
 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 | LIB |
| FDA Classification Name | DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 866.2660 |
| FDA Common Generic Name | H. PYLORI TEST KIT |
| FDA Proprietary Device Name | H. PYLORI TEST KIT |
| 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) |
RR - Repackager/Relabeller |
| FDA Listing Date | 07-07-96 |
| 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 | PML MICROBIOLOGICALS INC. 27120 SW 95TH AVENUE P.O. BOX 570 WILSONVILLE, OR 97070 US 704-870-0044 / 503-570-2500 125 |
QUALIFEST-PYR | TEST TO AID IN THE IDENTIFICATION OF ENTEROCOCCUS (PRESUMPTIVE) |
| 2 | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 US 847-937-6100 / 847-938-3471 |
ABBOTT M2000RT | AMPLIFICATION DETECTION SYSTEM |
| 3 | BD BIOSCIENCES DISCOVERY LABWARE ONE BECTON CIRCLE DURHAM, NC 27712 US 201-847-6800 / 978-901-7200 313 |
FALCON LABWARE-MULTIPLE | VARIOUS STYLES AND SIZES OF STERILE AND NON-STERILE DISPOSABLE ASSAY AND IMMUNOA |
| 4 | CASCO MANUFACTURING SOLUTIONS, INC. 3111 SPRING GROVE AVE. CINCINNATI, OH 45225 US 513-681-0003 / 513-681-0003 126 |
SEWN CLOTH SQUARES FOR STREPT TESTS | SAME |
| 5 | ELITECH FRANCE SAS PARC D'ACTIVITES ALLEE D'ATHENES SIGNES, 83870 FR 33-4-90175450 / 435-752-6011 |
PRESTO ABG | INOCULATOR |
| 6 | FOCUS DIAGNOSTICS, INC. 10703 PROGRESS WAY CYPRESS, CA 90630 US 714-220-1900 / 714-220-1900 2243 |
MULTIPLE PARVOVIRUS ELISA KITS AND COMPONENTS | VARIOUS PARVOVIRUS ELISA KITS AND COMPONENTS |
| 7 | GREINER MUANYAGTECHNIKA KFT FERTOSOR 7 MOSONMAGYAROVAR, H-9200 HU 004-375-8367910 / 43-758-367910 |
GREINER BIO-ONE PETRI DISHES | PETRI DISH |
| 8 | HEALTHLINK 3611 ST. JOHNS BLUFF RD. SOUTH SUITE 1 JACKSONVILLE, FL 32224 US 904-996-7758 / 904-996-7758 15 |
URI-ID | DIP PADDLE |
| 9 | MEDICAL WIRE AND EQUIPMENT CO. LTD. POTLEY CORSHAM, WILTSHIRE, SN13 9RT UK 44-122-5 810361 / 44-122-5 810153 |
MICRORING (EXCEPT FOR YT) | MICROBIOLOGICAL ID DEVICE |
| 10 | MICROBIOLOGICS, INC. 217 OSSEO AVE. NORTH ST. CLOUD, MN 56303 US 320-253-1640 / 320-253-1640 |
LYFO-KWIK OMI KIT | MICROORGANISM DIFFERENTIATION AND IDENTIFICATION DEVICE |
| 11 | OXOID, LTD. WADE RD. BASINGSTOKE, HAMPSHIRE, RG24 8PW UK 603-929-2650 / 412-490-8425 |
OBIS SALMONELLA AND PYR KITS | BIOCHEMICAL ID KITS |
| 12 | PARTER MEDICAL PRODUCTS, INC. 17011 KINGSVIEW AVE. CARSON, CA 90746 US 310-327-4417 / 310-327-4417 |
PETRI DISHES, PLASTIC DISPOSABLE | PETRI DISHES |
| 13 | PARTER STERILIZATION SERVICES, LLC 17115 KINGSVIEW AVENUE CARSON, CA 90746 US 310-327-4417 / 310-327-4417 |
PETRI DISHES,PLASTIC | PETRI DISHES |
| 14 | PML MICROBIOLOGICALS 27120 S.W. 95TH AVE. P.O. BOX 570 WILSONVILLE, OR 97070 US 503-570-2500 / 503-570-2500 125 |
MULTIPLE | MULTIPLE |
| 15 | REMEL EUROPE LTD REMEL HOUSE, CLIPPER BLVD. WEST CROSSWAYS DARTFORD, KENT, DA2 6PT UK 412-490-8425 / 412-490-8425 |
MULTIPLE | REACTION TUBES |
| 16 | REMEL, INC. 12076 SANTA FE DR. LENEXA, KS 66215 US 412-490-8425 / 412-490-8425 |
MULTIPLE | REACTION TUBES |
| 17 | SALUBRIS BIYOTEKNOLOJI URUNLERI SANAYI VE TICARET IDEALTEPE MAHALLESI AKGUVERCIN SOKAK NO: 9 MALTEPE ISTANBUL, 34841 TU 90-216-5184660 / 800-326-1484 |
HELICHECK | RAPID UREASE TEST |
| 18 | SIFIN INSTITUT FUR IMMUNPRAPARATE UND NAHRMEDIEN G BERLINER ALLEE 317-321 BERLIN, 13088 GM 49-30-9270300 / 49-30-92703083 |
TEST SERA ANTI-YERSINIA ENTEROCOLITICA | TEST SERA ANTI-YERSINIA ENTEROCOLITICA |
| 19 | VIROTEK, L.L.C. 900 ASBURY DR. BUFFALO GROVE, IL 60089 US 847-634-4500 260 / 818-665-4214 |
INOCULATING LOOP | INOCULATING LOOP |
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