IMMUNOWELL RNP/Sm ANTIBODY TEST MANUFACTURED BY GENBIO

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Request for Information Form	Contact Information
Company Name	GENBIO
Address	15222 AVE. OF SCIENCE, SUITE A
City, State, Zip	SAN DIEGO, CA 92128
Country	US
FDA Owner/Operator Phone	858-592-9300 309
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	LKO
FDA Classification Name	ANTI-RNP ANTIBODY, ANTIGEN AND CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5100
FDA Common Generic Name	ENZYME - LINKED IMMUNOASSAY - FOR RNP/SM ANTIBODIES
FDA Proprietary Device Name	IMMUNOWELL RNP/Sm ANTIBODY TEST
FDA Owner / Operator Number	2027113
FDA Owner / Operator Name	GENBIO
FDA Establishment Registration Number	2027113
FDA Registered Establishment Name	GENBIO
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-18-92
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263	ENZYME IMMUNOASSAY ANTI-SMRNP ANTIBODY TEST KIT	ENZYME IMMUNOASSAY ANTI-SMRNP ANTIBODY TEST KIT
2	CORGENIX, INC. 11575 MAIN ST. SUITE 400 BROOMFIELD, CO 80020 US 303-457-4345 / 303-457-4345 130	MULTIPLE	RNP ANTIBODIES
3	HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111	AUTOSTAT II ANTI SM/RNP ELISA	AUTOSTAT II SM/RNP ELISA
4	IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228 US 716-691-0091 / 716-691-0091	ANTI-RNP POSITIVE CONTROL	ANTI-RNP POSITIVE CONTROL
5	MBL INTERNATIONAL CORP. 15 B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964	RHIGENE MESACUP-2 TEST - RNP	RNP ELISA KIT
6	MBL INTERNATIONAL CORPORATION 15B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964	MESACUP-2 TEST RNP	ANTI-RNP ELISA TEST
7	ORGENTEC DIAGNOSTIKA GMBH CARL-ZEISS-STRASSE 49 MAINZ, 55129 GM 011-49-613192580 / 763-780-2955	ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY	ANTI-RNP/SM
8	PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278	MULTIPLE	ANTI RNP ANTIBODIES, ANTIGEN AND CONTROLS
9	QUEST INTL., INC. 1938 N.E. 148TH TERR. NORTH MIAMI, FL 33181 US 305-948-8788 / 305-948-8788	SERAQUEST ANTI-SM/RNP	ANTI-SM/RNP SEROLOGICAL REAGENTS, ELISA