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ICHEM 100 URINE CHEMISTRY ANALYZER
 Request for Information Form |
 Contact Information
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| Company Name | IRIS DIAGNOSTICS |
| Address | 9172 ETON AVE. |
| City, State, Zip | CHATSWORTH, CA 91311 |
| Country | US |
| FDA Owner/Operator Phone | 818-709-1244 7129 |
| FDA Medical Specialty Code | CH - Clinical Chemistry |
| FDA Product Code | JIL |
| FDA Classification Name | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 862.1340 |
| FDA Common Generic Name | SEMI-AUTOMATED URINE CHEMISTRY ANALYZER |
| FDA Proprietary Device Name | ICHEM 100 URINE CHEMISTRY ANALYZER |
| FDA Owner / Operator Number | 2023446 |
| FDA Owner / Operator Name | IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I |
| FDA Establishment Registration Number | 2023446 |
| FDA Registered Establishment Name | IRIS DIAGNOSTICS |
| FDA Operation Code(s) |
MS - Specification Developer |
| FDA Listing Date | 10-09-06 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of IRIS DIAGNOSTICS
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 | ACON BIOTECH (HANGZHOU) CO., LTD. 398 TIANMUSHAN RD. GUDANG INDUSTRIAL PARK HANGZHOU, P.R., 310023 CH 86-571-03963569 / 858-875-8000 1828 |
ACON URINALYSIS REAGENT STRIPS | URINALYSIS REAGENT STRIPS |
| 2 | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US 858-535-2030 / 858-875-8000 1828 |
ACON URINALYSIS REAGENT STRIPS | URINALYSIS REAGENT STRIPS |
| 3 | AMERITECH DIAGNOSTIC JIANXIAN REAGENT CO., LTD. 2018 QING FENG SOUTH ROAD TONG XIANG, ZHEJIANG, 314500 CH 425-379-2580 / 425-379-2580 |
DBEST URINE STRIP (URINALYSIS) | URINE STRIP |
| 4 | AMERITEK USA, INC. 125 130 ST. SE, #200 EVERETT, WA 98208 US 425-379-2580 / 425-379-2580 |
DBEST URNINALYSIS STRIPS | URINALYSIS STRIPS |
| 5 | ANALYTICON BIOTECHNOLOGIES AG AM MUEHLENBERG 10 LICHTENFELS, 35104 GM 49-645-4 7991 0 / 847-374-8854 |
COMBISCREEN 10SL AND 11SL | URINARY GLUCOSE (ANONQUANTITATIVE) TEST SYSTEM |
| 6 | ARJ MEDICAL, INC. 209 STATE STREET OLDSMAR, FL 34677 US 813-855-1557 / 813-855-1557 |
URITEST 10 URINALYSIS REAGENT STRIPS | URINALYSIS REAGENT STRIPS |
| 7 | ARKRAY FACTORY INC. 1480 KOJI,KONAN-CHO, KOKA-SHI SHIGA,, 520-3306 JA 81-75-6628964 / 81-748-867298 |
AUTION STICKS 10TA | URINE TEST STRIP |
| 8 | ARKRAY FACTORY USA, INC. 5182 WEST 76TH ST. MINNEAPOLIS, MN 55439 US 81-75-6628964 / 952-646-3168 |
DIASCREEN REAGENT STRIPS FOR URINALYSIS | URINE TEST STRIPS |
| 9 | ARKRAY, INC. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU KYOTO, 601-8045 JA 81-75-6628964 / 81-748-867298 |
AUTION STICKS 10TA | URINE TEST STRIP |
| 10 | BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. 5TH FLOOR TARRYTOWN, NY 10591 US 914-524-2955 / 574-262-6372 |
DIASTIX | TEST FOR GLUCOSE IN URINE |
| 11 | BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. MISHAWAKA, IN 46544 US 914-524-2955 / 574-256-3430 |
MULTIPLE | MULTIPLE |
| 12 | BTNX, INC. 570 HOOD ROAD, UNIT 23 MARKHAM, L3R 4G7 CA 905-944-9565 / 303-234-9412 |
BIOTECHNOSTIX | URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM |
| 13 | CENOGENICS CORP. 100 RT. 520 MORGANVILLE, NJ 07751 US 732-536-6457 / 732-536-6457 |
CHEMVIEW-10 | REAGENT TEST STRIP FOR URINALYSIS |
| 14 | CHUNG-DO PHARMACEUTICAL CO.,LTD. #1111 YEOJEONDO-BLDG. 1-1 , YEONJI-DONG,CHONGRO-KU SEOUL, 110-470 KS |
BIOSCAN REAGENT STRIPS | URINE TEST REAGENT STRIPS |
| 15 | COLE-TAYLOR MARKETING, INC. 7952 GENESTA AVENUE VAN NUYS, CA 91406 US 818-776-9992 / 321-299-2521 |
900-10 URINE REAGENT STRIP | URINE TEST STRIP |
| 16 | DFI CO., LTD. 542-1 DAMAN-RI, JINRYE-MYUN GIMHAE-CITY, GYUNG-NAM, KS 82-55-3461882 / 909-980-9933 |
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS | URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM |
| 17 | DIRUI INDUSTRIAL CO., LTD. 95 YUNHE ST., NEW & HIGH TECH DEVELOPMENT ZONE CHANGCHUN, 130012 CH 86-431-5100409 / 516-482-9001 |
DIRUI | MULTIPLE REAGENT STRIPS |
| 18 | DR. BRUNO LANGE GMBH KOENIGSWEG 10 BERLIN, 14163 GM |
LCK 191 BLOOD SUGAR-ENZYMATIC | REAGENT GLUCOSE |
| 19 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
GLOBALEMED URINE REAGENT STRIPS | URINE REAGENT STRIPS |
| 20 | IND DIAGNOSTIC INC. 1629 FOSTERS WAY DELTA, BC, V3M 6S7 CA 604-522-1619 / 604-522-1619 |
URINALYSIS REAGENT STRIP (10 PARAMETER) | URINALYSIS KIT |
| 21 | IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 331 SOUTH 104TH ST. LOUISVILLE, CO 80027 US 781-674-3900 / 303-530-6612 |
URINE TEST STRIP | URINE TEST STRIP |
| 22 | JANT PHARMACAL CORP. 16255 VENTURA BLVD., SUITE 505 ENCINO, CA 91436 US 818-986-8530 / 818-986-8530 |
ACCUTEST URS URINE REAGENT STRIPS | TYPES OF URINALYSIS KITS |
| 23 | KIMBALL ELECTRONICS (WALES) LIMITED WESTERN AVENUE BRIDGEND INDUSTRIAL ESTATE BRIDGEND, WALES, CF31 3TY UK 812-634-4172 / 44-163-5566448 |
DIASTIX | TEST FOR GLUCOSE IN URINE |
| 24 | LRE MEDICAL GMBH HOFER STRASSE 5 NOERDLINGEN, 86720 GM 49-908-18000 / 208-765-8000 1247 |
URYXXON 200 URINE ANALYZER | URYXXON 200 URINE ANALYZER |
| 25 | MACHEREY-NAGEL GMBH & CO., KG. NEUMANN-NEANDER-STRASSE 6-8 DUEREN, 52355 GM 49-242-1969259 / 49-242-1969259 |
URYXXON RELAX | URINALYSIS INSTRUMENT |
| 26 | MYM LABORATORY & MEDICAL SUPPLY, INC. 8684 AVENUE DE LA FUENTE SUITE 14 SAN DIEGO, CA 92154 US 619-710-0126 / 619-710-0126 |
URIANALYSIS REAGENT STRIP(10 PARAMETERS) | URIANALYSIS KIT |
| 27 | NEO PHARM INC. 10532 WALKER ST., SUITE #B CYPRESS, CA 90630 US 714-226-0070 / 714-226-0070 |
MULTIPLE | URINARY GLUCOSE (NON-QUANTITATIVE) TEST SYSTEM |
| 28 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
MULTIPLE | MULTIPLE |
| 29 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 3400 MIDDLEBURY ST. ELKHART, IN 46514 US 914-524-2955 / 914-524-2955 |
DIASTIX | TEST FOR GLUCOSE IN URINE |
| 30 | STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772 |
URI-QUICK 10SG | URINARY GLUCOSE |
| 31 | SYSTEMS COMPLETE, LLC. 265 SOBRANTE WAY, SUITE M SUNNYVALE, CA 94086 US 408-773-1750 / 408-773-1750 |
EARLY-CARE "TM" GLUCOSE REAGENT STRIPS FOR URINALYSIS | GLUCOSE REAGENT STRIPS |
| 32 | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788 |
URINE REAGENT STRIPS | URINE REAGENT STRIPS |
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