MICRO-PLATE MANUFACTURED BY ORASURE TECHNOLOGIES, INC.

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MICRO-PLATE

Request for Information Form	Contact Information
Company Name	ORASURE TECHNOLOGIES, INC.
Address	1745 EATON AVE.
City, State, Zip	BETHLEHEM, PA 18018
Country	US
FDA Owner/Operator Phone	610-882-1820
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CKA
FDA Classification Name	NADH OXIDATION/NAD REDUCTION, ALT/SGPT
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1030
FDA Common Generic Name	ALANINE AMINOTRANSFER (ALT/SGPT)
FDA Proprietary Device Name	MICRO-PLATE
FDA Owner / Operator Number	9000083
FDA Owner / Operator Name	ORASURE TECHNOLOGIES, INC.
FDA Establishment Registration Number	2528909
FDA Registered Establishment Name	ORASURE TECHNOLOGIES, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	03-11-95
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ORASURE TECHNOLOGIES, INC.

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 ALT TEST SYSTEM	ALT TEST SYSTEM
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOIUS ASSAYS FOR DETECTION OF SGPT (ALT)
3	ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOIUS ASSAYS FOR DETECTION OF SGPT (ALT)
4	AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 SOLON, OH 44139 US 440-349-1199 / 440-914-3409	AMRESCO ALT-IFCC REAGENT	ALT REAGENT
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	ALT
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	ALT
7	BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. 5TH FLOOR TARRYTOWN, NY 10591 US 914-524-2955 / 574-262-6372	NO PROPRIETARY NAME LISTED	TEST FOR SGPT IN PLASMA OR SERUM
8	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	BECKMAN ENZYMATIC ALT REAGENT KIT	SGPT REAGENT KIT
9	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	ALT REAGENT
10	BIO PHASE DIAGNOSTICS LABORATORY 6625 KITIMAT RD., UNIT #51 MISSISSAUGA, ONTARIO, L5N 6J1 CA 905-567-9165 / 905-567-9165	ALANINE TRANSAMINASE	NADH OXIDATION/NAD REDUCTION, ALT/SGPT
11	CALDON BIOSCIENCE, INC. 2100 SOUTH RESERVOIR ST. POMONA, CA 91766 US 909-628-9944 / 909-628-9944	ALT/SGPT	ALT/SGPT
12	CALDON BIOTECH, INC. 2251 RUTHERFORD RD. CARLSBAD, CA 92008 US 760-804-7378 / 760-804-7378 305	ALT/SGPT	ALT/SGPT
13	CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272	CAROLINA LIQUID CHEMISTRIES ALT REAGENT	ALT
14	CATACHEM, INC. 70 HAWLEY AVE. BRIDGEPORT, CT 06606 US 203-335-9277 / 203-335-9277	ALT	ALT/GPT
15	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS ALT/SGPT METHODS
16	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
17	DIASYS DIAGNOSTICS SYSTEMS GMBH ALTE STRASSE 9 HOLZHEIM, RHEINLAND-PFALZ, D-65558 GM 49-643-291460 / 954-433-7480 144	ALAT (GPT) FS (IFCC MOD.)	ALT (SGPT)
18	DR. BRUNO LANGE GMBH KOENIGSWEG 10 BERLIN, 14163 GM	LCK 177 S.G.P.T.	REAGENT S.G.P.T.
19	EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605	NO PROPRIETARY NAME LISTED	ALT / AGPT NAD REDUCTION
20	EGYPTIAN CO. FOR BIOTECHNOLOGY BLDG 19A, BLOCK 20008, STREET 163 OBOUR CITY, CAIRO, EG 2-02-6651848 / 2-02-6651848	SPECTRUM DIAGNOSTICS ALT/SGPT TEST SYSTEM	ALANINE AMINO TRANSFERASE TEST SYSTEM
21	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	ALT/SGPT SET	ALT/SGPT SET
22	EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. EXTON, PA 19341 US 617-252-7500 / 617-768-6275	BIOTROL ALT/TGP MONOREACTIF	ALANINE AMINOTRANSFERASE
23	GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 BREA, CA 92821 US 714-529-7125 / 714-529-7166	ALT/SGPT	ALT/SGPT REAGENT
24	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	NADH OXIDATION/NAD REDUCTION, ALT/SGPT	NADH OXIDATION/NAD REDUCTION, ALT/SGPT
25	HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501	MULTIPLE	VARIOUS ALT/SGPT METHODS
26	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92	MULTIPLE	ALANINE AMINOTRANSFERASE
27	INTERNATIONAL BIO-ANALYTICAL INDUSTRIES, INC. 3595 NORTH DIXIE HWY., UNIT 5 BOCA RATON, FL 33431 US 561-826-0061 / 561-826-0061	GLUTAMIC PYRUVIC TRANSAMINASE	GLUTAMIC PYRUVIC TRANSAMINASE
28	JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320	ALT (GPT)	ALT (GPT)
29	KING DIAGNOSTICS, INC. 980 PARK CTR. DR. SUITE F,G VISTA, CA 92081 US 760-597-1182 / 760-597-1182	ALT/SGPT	ALT/SGPT
30	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688	OLYMPUS ALANINE AMINOTRANSFERASE REAGENT	ALANINE AMINOTRANSFERASE REAGENT
31	ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	MULTIPLE	ALANINE AMINO TRANSFERASE (ALT/SGPT) TEST SYSTEM
32	POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US 734-487-8300 / 734-487-8310	ALANINE AMINOTRANSFERASE	ALT (SGPT)
33	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363	POLYMEDCO POLY-CHEM SYSTEM, ALANINE AMINOTRANSFERASE (ALT)	ALANINE AMINOTRANSFERASE, ALT, SGPT
34	R. J. HARVEY INSTRUMENT CORP. 123 PATTERSON ST. HILLSDALE, NJ 07642 US 201-664-1380 / 201-664-1380		ALT/SGPT 3450
35	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX ALT	ALT
36	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX ALT	ALT
37	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX ALT	ALT
38	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX ALT	ALT
39	REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501	RAICHEM GPT (ALT) REAGENT	SERUM GLUTAMATE PYRUVATE TRANSAMINASE SGPT (ALT)
40	ROMARK 80 EARHART DR., UNIT 3 WILLIAMSVILLE, NY 14221 US 201-664-1380 / 201-664-1380		ALT/SGPT 3450
41	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
42	STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
43	STERLING DIAGNOSTICS, INC. 36645 METRO COURT STERLING HEIGHTS, MI 48312 US 810-979-9171 / 810-979-2141		ALT/SGPT REAGENT SET
44	SYNERMED INTL., INC. 17408 TILLER COURT, STE. 1900 WESTFIELD, IN 46074 US 317-896-1565 / 317-896-1565	SYNERMED ALT/GPT REAGENT KIT	ALT/GPT REAGENT KIT
45	TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788	ALT LIQUID REAGENT	ALT LIQUID REAGENT
46	THERMO FISHER SCIENTIFIC 189-199 BROWNS RD. NOBLE PARK, VICTORIA, 3174 AS / 613-979-04100	TRACE ALT (GPT) REAGENT	ALANINE AMINOTRANSFERASE (ALT/SGPT)
47	VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553	MULTIPLE	VARIOUS ALT/SGPT REAGENTS
48	WIENER LABORATORIOS S.A.I.C. 2571 MAIPU ROSARIO SANTA FE, 2000 AR 011-543-414851982 / 011-543-414851982	MULTIPLE	VARIOUS