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DIRECT CREATININE TEST SET
 Request for Information Form |
 Contact Information
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| Company Name | STANBIO LABORATORY |
| Address | 1261 NORTH MAIN ST. |
| City, State, Zip | BOERNE, TX 78006 |
| Country | US |
| FDA Owner/Operator Phone | 830-249-0772 |
| FDA Medical Specialty Code | CH - Clinical Chemistry |
| FDA Product Code | CGX |
| FDA Classification Name | ALKALINE PICRATE, COLORIMETRY, CREATININE |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 862.1225 |
| FDA Common Generic Name | MODIFIED JAFFE (CREATININE ALKALINE PICRATE) PROCEDURE |
| FDA Proprietary Device Name | DIRECT CREATININE TEST SET |
| FDA Owner / Operator Number | 1616487 |
| FDA Owner / Operator Name | STANBIO LABORATORY |
| FDA Establishment Registration Number | 1616487 |
| FDA Registered Establishment Name | STANBIO LABORATORY |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of STANBIO LABORATORY
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 | ABAXIS, INC. 3240 WHIPPLE RD. UNION CITY, CA 94587 US 510-675-6500 / 510-675-6518 |
PICCOLO CREATININE TEST SYSTEM | CREATININE TEST SYSTEM |
| 2 | ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471 |
CREA | CREATININE |
| 3 | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 SOLON, OH 44139 US 440-349-1199 / 440-914-3409 |
AMRESCO CREATININE REAGENT | CREATININE REAGENT |
| 4 | ARKRAY FACTORY INC. 1480 KOJI,KONAN-CHO, KOKA-SHI SHIGA,, 520-3306 JA 81-75-6628964 / 81-748-867298 |
SPOTCHEM II CHEMISTRY BASIC 1 | CREATININE |
| 5 | ARKRAY, INC. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU KYOTO, 601-8045 JA 81-75-6628964 / 81-748-867298 |
SPOTCHEM II CHEMISTRY BASIC 1 | CREATININE |
| 6 | BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. 5TH FLOOR TARRYTOWN, NY 10591 US 914-524-2955 / 574-262-6372 |
DCA 2000+ MICROALBUMIN/CREATININE ASSAY | TEST FOR CREATININE |
| 7 | BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383 |
LIQUID-STAT CREATININE REAGENT | CREATININE ANALYSIS PRODUCT |
| 8 | BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383 |
MULTIPLE | CREATININE REAGENT |
| 9 | BIO PHASE DIAGNOSTICS LABORATORY 6625 KITIMAT RD., UNIT #51 MISSISSAUGA, ONTARIO, L5N 6J1 CA 905-567-9165 / 905-567-9165 |
CREATININE | ALKALINE PICRATE, COLORIMETRY, CREATININE |
| 10 | CALDON BIOSCIENCE, INC. 2100 SOUTH RESERVOIR ST. POMONA, CA 91766 US 909-628-9944 / 909-628-9944 |
CREATININE | CREATININE |
| 11 | CALDON BIOTECH, INC. 2251 RUTHERFORD RD. CARLSBAD, CA 92008 US 760-804-7378 / 760-804-7378 305 |
CREATININE | CREATININE |
| 12 | CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272 |
CAROLINA LIQUID CHEMISTRIES CREATININE REAGENT | CREAT |
| 13 | CATACHEM, INC. 70 HAWLEY AVE. BRIDGEPORT, CT 06606 US 203-335-9277 / 203-335-9277 |
CREATININE | CREATININE |
| 14 | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311 |
MULTIPLE | VARIOUS CREATININE METHODS |
| 15 | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396 |
CREATININE ASSAY | CREATININE ASSAY |
| 16 | DIAGNOSTIC SPECIALTIES 4 LEONARD ST. METUCHEN, NJ 08840 US 732-549-4011 / 732-549-4011 |
CREATININE REAGENT SET | CREATININE REAGENT SET |
| 17 | DR. BRUNO LANGE GMBH KOENIGSWEG 10 BERLIN, 14163 GM |
LCK 109 CREATININE | REAGENT CREATININE |
| 18 | EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605 |
NO PROPRIETARY NAME LISTED | ALKALINE PICRATE COLORIMETRY CREATININE |
| 19 | EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 20 | EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. EXTON, PA 19341 US 617-252-7500 / 617-768-6275 |
BIOTROL CREATININE HP | CREATININE |
| 21 | FLEXSITE DIAGNOSTICS, INC. 3543 S.W. CORPORATE PKWY. PALM CITY, FL 34990 US 772-221-8893 / 772-221-8893 114 |
HOME SAMPLING KIT FOR SELF MONITORING OF URINARY MICROALBUMIN | HOME SAMPLING KIT FOR SELF MONITORING OF URINARY MICROALBUMIN |
| 22 | GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 BREA, CA 92821 US 714-529-7125 / 714-529-7166 |
CREATININE | CREATININE REAGENT |
| 23 | GLOBAL BUSINESS SUPPORT SYSTEMS, INC. 9520 CHESAPEAKE DRIVE, #601 SAN DIEGO, CA 92123 US 858-430-2800 / 858-430-2800 112 |
KIT FOR SELF MONITORING URINARY MICROALBUMI | KIT FOR SELF MONITORING URINARY MICROALBUMI |
| 24 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
CAPILLARY ADAPTOR ACCESSORY MULTIPLE DIAGNOSIS PRODUCTS | CAPILLARY ADAPTOR ACCESSORY MULTIPLE DIAGNOSIS PRODUCTS |
| 25 | HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845 |
ALKALINE PICRATE, COLORIMETRY, CREATININE | ALKALINE PICRATE, COLORIMETRY, CREATININE |
| 26 | HERITAGE LABS INTL., LLC 1111 WEST OLD 56 HWY. OLATHE, KS 66061 US / 913-764-1045 |
ALKALINE PICRATE, COLORIMETRY, CREATININE | APPRAISE URINE MICROALBUMIN COLLECTION KIT |
| 27 | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92 |
MULTIPLE | CREATININE |
| 28 | INTERNATIONAL BIO-ANALYTICAL INDUSTRIES, INC. 3595 NORTH DIXIE HWY., UNIT 5 BOCA RATON, FL 33431 US 561-826-0061 / 561-826-0061 |
CREATININE, DIRECT CREATININE-KINETIC | CREATININE, DIRECT CREATININE-KINETIC |
| 29 | INTERSECT SYSTEMS, INC. 1152 3RD AVE. SUITE D/E LONGVIEW, WA 98632 US 360-577-1062 / 360-577-1062 |
DUAL VIAL CREATININE REAGENT | CREATININE REAGENT |
| 30 | JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320 |
CREATININE | CREATININE |
| 31 | KING DIAGNOSTICS, INC. 980 PARK CTR. DR. SUITE F,G VISTA, CA 92081 US 760-597-1182 / 760-597-1182 |
CREATININE | CREATININE |
| 32 | MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425 |
MULTIPLE | URINE CREATINE TEST |
| 33 | MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425 |
MULTIPLE | URINE CREATINE TEST |
| 34 | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211 |
NOVA NUCLEUS CHEMISTRY SYSTEM | NOVA NUCLEUS CHEMISTRY SYSTEM |
| 35 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688 |
OLYMPUS CREATININE REAGENT | CREATININE REAGENT |
| 36 | ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. BETHLEHEM, PA 18018 US 610-882-1820 / 610-882-1820 5043 |
AUTO-LYTE URINARY CREATINE ASSAY | URINARY CREATINE ASSAY |
| 37 | POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US 734-487-8300 / 734-487-8310 |
CREATININE | |
| 38 | POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363 |
POLYMEDCO POLY-CHEM SYSTEM, CREATININE | CREATININE |
| 39 | PPR DIAGNOSTICS LTD. 150 STAMFORD STREET LONDON, SE1 9NN UK 44-192-3842978 / 248-808-3612 |
N-A-G TEST KIT | CREATININE TEST SYSTEM |
| 40 | R. J. HARVEY INSTRUMENT CORP. 123 PATTERSON ST. HILLSDALE, NJ 07642 US 201-664-1380 / 201-664-1380 |
CREATININE 3259 | |
| 41 | RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413 |
RANDOX CREATININE | CREATININE |
| 42 | RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413 |
RANDOX CREATININE | CREATININE |
| 43 | RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413 |
RANDOX CREATININE | CREATININE |
| 44 | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413 |
RANDOX CREATININE | CREATININE |
| 45 | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501 |
RAICHEM | CREATININE REAGENT |
| 46 | ROMARK 80 EARHART DR., UNIT 3 WILLIAMSVILLE, NY 14221 US 201-664-1380 / 201-664-1380 |
CREATININE 3259 | |
| 47 | ROWLEY BIOCHEMICAL INSTITUTE, INC. 10 ELECTRONICS AVE. DANVERS INDUSTRIAL PARK DANVERS, MA 01923 US 978-739-4883 / 978-739-4883 |
CREATINE TEST KIT,ALKALINE PICRATE | CREATINE TEST KIT,ALKALINE PICRATE |
| 48 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
ADVIA 1650 CREATININE, JAFFE ASSAY | CREATININE, JAFFE ASSAY |
| 49 | SITA ASSOCIATES 720 WILLIAMSBURG COURT OAK BROOK, IL 60523 US 630-968-3727 / 630-968-3727 |
MULTIPLE (CREATININE TEST KITS FOR URINE & SERUM/AMNIOTIC FL | RAPID CREATININE TEST KITS FOR URINE AND SERUM/AMNIOTIC FLUID |
| 50 | STERLING DIAGNOSTICS, INC. 36645 METRO COURT STERLING HEIGHTS, MI 48312 US 810-979-9171 / 810-979-2141 |
CREATININE REAGENT SET | |
| 51 | SYNERMED INTL., INC. 17408 TILLER COURT, STE. 1900 WESTFIELD, IN 46074 US 317-896-1565 / 317-896-1565 |
SYNERMED CREATINE REAGENT KIT | CREATINE REAGENT KIT |
| 52 | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788 |
CREATININE | |
| 53 | THERMO FISHER SCIENTIFIC 189-199 BROWNS RD. NOBLE PARK, VICTORIA, 3174 AS / 613-979-04100 |
CREATININE REAGENT PICRIC ACID METHOD, INFINITY CREATININE LIQUID STABLE REAGENT | CREATININE TEST SYSTEM |
| 54 | VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553 |
MULTIPLE | VARIOUS CREATININE REAGENTS |
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