BILIRUBIN TEST SET MANUFACTURED BY STANBIO LABORATORY

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BILIRUBIN TEST SET

Request for Information Form	Contact Information
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	CIG
FDA Classification Name	DIAZO COLORIMETRY, BILIRUBIN
FDA Device Classification Code	Standards
FDA Regulation Number	862.1110
FDA Common Generic Name	DIAZO PROCEDURE FOR TOTAL AND DIRECT BILIRUBIN
FDA Proprietary Device Name	BILIRUBIN 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 TOTAL BILIRUBIN TEST SYSTEM, PICCOLO DIRECT BILIRUBIN TEST SYSTEM	TOTAL BILIRUBIN TEST SYSTEM, DIRECT BILIRUBIN TEST SYSTEM
2	ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471	MULTIPLE	TOTAL BILIRUBIN, DIRECT BILIRUBIN
3	ADVANCED INSTRUMENTS, INC. TWO TECHNOLOGY WAY NORWOOD, MA 02062 US 781-320-9000 2179 / 617-320-9000	BILIRUBINOMETER	BILIRUBIN COLORIMETER
4	AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 SOLON, OH 44139 US 440-349-1199 / 440-914-3409	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
5	ARKRAY FACTORY INC. 1480 KOJI,KONAN-CHO, KOKA-SHI SHIGA,, 520-3306 JA 81-75-6628964 / 81-748-867298	SPOTCHEM II CHEMISTRY BASIC 2	TOTAL BILIRUBIN
6	ARKRAY, INC. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU KYOTO, 601-8045 JA 81-75-6628964 / 81-748-867298	SPOTCHEM II CHEMISTRY BASIC 2	TOTAL BILIRUBIN
7	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	LIQUID-STAT BILIRUBIN REAGENT	BILIRUBIN (TOTAL AND DIRECT) ANALYSIS PRODUCTS
8	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	BILIRUBIN REAGENT
9	BIO PHASE DIAGNOSTICS LABORATORY 6625 KITIMAT RD., UNIT #51 MISSISSAUGA, ONTARIO, L5N 6J1 CA 905-567-9165 / 905-567-9165	BILIRUBIN	DIAZO COLORIMETRY, BILIRUBIN
10	CALDON BIOSCIENCE, INC. 2100 SOUTH RESERVOIR ST. POMONA, CA 91766 US 909-628-9944 / 909-628-9944	BILIRUBIN	BILIRUBIN
11	CALDON BIOTECH, INC. 2251 RUTHERFORD RD. CARLSBAD, CA 92008 US 760-804-7378 / 760-804-7378 305	BILIRUBIN	BILIRUBIN
12	CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272	TOTAL BILIRUBIN	BILIRUBIN REAGENT
13	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS BILIRUBIN METHODS
14	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396	BILIRUBIN ASSAY (TOTAL)	BILIRUBIN ASSAY (TOTAL)
15	DIAGNOSTIC SPECIALTIES 4 LEONARD ST. METUCHEN, NJ 08840 US 732-549-4011 / 732-549-4011	BILIRUBIN REAGENT SET	BILIRUBIN REAGENT SET
16	DR. BRUNO LANGE GMBH KOENIGSWEG 10 BERLIN, 14163 GM	LCK 102 BILIRUBINE	REAGENT BILIRUBINE
17	EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
18	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
19	GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 BREA, CA 92821 US 714-529-7125 / 714-529-7166	TOTAL BILIRUBIN	TOTAL BILIRUBIN REAGENT
20	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	BILIRUBIN MULTIPLE DIAGNOSIS	BILIRUBIN MULTIPLE DIAGNOSIS
21	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	DIAZO COLORIMETRY, BILIRUBIN	DIAZO COLORIMETRY, BILIRUBIN
22	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92	MULTIPLE	BILIRUBIN
23	INTERNATIONAL BIO-ANALYTICAL INDUSTRIES, INC. 3595 NORTH DIXIE HWY., UNIT 5 BOCA RATON, FL 33431 US 561-826-0061 / 561-826-0061	TOTAL & DIRECT BILIRUBIN	TOTAL & DIRECT BILIRUBIN
24	INTERSECT SYSTEMS, INC. 1152 3RD AVE. SUITE D/E LONGVIEW, WA 98632 US 360-577-1062 / 360-577-1062	TOTAL BILIRUBIN REAGENT	TOTAL BILIRUBIN
25	JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320	BILIRUBIN (TOTAL & DIRECT)	BILIRUBIN (TOTAL & DIRECT)
26	KING DIAGNOSTICS, INC. 980 PARK CTR. DR. SUITE F,G VISTA, CA 92081 US 760-597-1182 / 760-597-1182	TOTAL BILIRUBIN	BILIRUBIN
27	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211	STAT PROFILE CRITICAL CARE XPRESS	BLOOD GAS,ELECTROLYTE,METABOLITE ANALYZER
28	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688	OLYMPUS DIRECT BILIRUBIN REAGENT AND TOTAL BILIRUBIN REAGENT	DIRECT BILIRUBIN REAGENT AND TOTAL BILIRUBIN REAGENT
29	OPTIMA, INC. ROGIE BLDG. 5F, 1-48-11 ITABASHI, ITABASHI-KU TOKYO, 173-0004 JA 81-353-752351 / 847-758-8834	DIAZO COLORIMETRY, BILIRUBIN	DIAZO COLORIMETRY, BILIRUBIN
30	ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	VITROS CHEMISTRY PRODUCTS TBIL SLIDES	BILIRUBIN (TOTAL OR DIRECT) TEST SYSTEM
31	POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US 734-487-8300 / 734-487-8310		TOTAL BILIRUBIN
32	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363	POLYMEDCO POLY-CHEM SYSTEM, TOTAL AND DIRECT BILIRUBIN	TOTAL BILIRUBIN, TBIL; DIRECT BILIRUBIN, DBIL, CONJUGATED BILIRUBIN
33	R. J. HARVEY INSTRUMENT CORP. 123 PATTERSON ST. HILLSDALE, NJ 07642 US 201-664-1380 / 201-664-1380		BILIRUBIN (TOTAL) 3258
34	RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ, DK-2700 DA 45-38-273827 / 45-38-273617	MULTIPLE	VARIOUS MODELS OF BLOOD ANALYZERS
35	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX BILIRUBIN	BILIRUBIN
36	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX BILIRUBIN	BILIRUBIN
37	REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501	REAGENT - DETERMINATION OF TOTAL & DIRECT BILLIRUBIN	REAGENT FOR DETERMINATION OF TOTAL & DIRECT BILLIRUBIN
38	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	MULTIPLE	BILIRUBIN
39	ROMARK 80 EARHART DR., UNIT 3 WILLIAMSVILLE, NY 14221 US 201-664-1380 / 201-664-1380		BILIRUBIN (TOTAL) 3258
40	SANDARE INTL., INC. 910 K.C.K. WAY CEDAR HILL, TX 75104 US 972-293-7440 / 972-293-7440	EAGLE DIAGNOSTICS TOTAL AND DIRECT BILIRUBIN PROCEDURES	DIAZO TOTAL AND DIRECT BILIRUBIN METHODS
41	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	ADVIA 1650 BILIRUBIN, DIRECT ASSAY	BILIRUBIN, DIRECT ASSAY
42	STERLING DIAGNOSTICS, INC. 36645 METRO COURT STERLING HEIGHTS, MI 48312 US 810-979-9171 / 810-979-2141		TOTAL AND DIRECT BILIRUBIN REAGENT SET
43	SYNERMED INTL., INC. 17408 TILLER COURT, STE. 1900 WESTFIELD, IN 46074 US 317-896-1565 / 317-896-1565	SYNERMED DIRECT BILIRUBIN REAGENT KIT, TOTAL BILIRUBIN REAGENT KIT,	DIRECT BILIRUBIN REAGENT KIT, TOTAL BILIRUBIN REAGENT KIT
44	TECHNOMART, INC. ACE-TECHNO TOWER II-307,#197-7 KURO-DONG, KURO-GU SEOUL, 152-848 KS 822-862-3434 / 847-758-8834	OPTIMA	OPTIMA
45	TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788	BILIRUBIN, DIRECT	BILIRUBIN, DIRECT
46	THERMO FISHER SCIENTIFIC 189-199 BROWNS RD. NOBLE PARK, VICTORIA, 3174 AS / 613-979-04100	TRACE TOTAL/DIRECT BILIRUBIN REAGENT	TOTAL AND DIRECT BILIRUBIN
47	VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553	MULTIPLE	VARIOUS TOTAL AND DIRECT BILIRUBIN REAGENTS
48	WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US 816-620-33741 / 650-210-9153 109	NONE	BILIRUBIN (TOTAL & DIRECT)
49	WAKO PURE CHEM., DIAG. RESEARCH LABS 6-1 TAKADA-CHO AMAGASAKI, HYOGO-KEN, 661-0963 JA 816-620-33741 / 650-210-9153 109	DIRECT BILIRUBIN V AND TOTAL BILIRUBIN V	DIRECT BILIRUBIN, TOTAL BILIRUBIN
50	WAKO PURE CHEMICAL INDUSTRIES, LTD. 2613-2 OAZA OGOHARA KOMONO-CHO MIE, 510-1222 JA 816-620-33741 / 650-210-9153 109	DIRECT BILIRUBIN V AND TOTAL BILIRUBIN V	DIRECT BILIRUBIN, TOTAL BILIRUBIN
51	WIENER LABORATORIOS S.A.I.C. 2571 MAIPU ROSARIO SANTA FE, 2000 AR 011-543-414851982 / 011-543-414851982	BILIRRUBINA TOTAL AA & BILIRRUBINA DIRECT AA	COLORIMETRIC METHOD FOR TOTAL & DIRECT BILIRUBIN ASSAY IN BLOOD & BIOLOG FLUIDS.