MULTIPLE HERPES SIMPLEX KITS MANUFACTURED BY MP BIOMEDICALS DIAGNOSTICS DIVISION

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MULTIPLE HERPES SIMPLEX KITS

Request for Information Form	Contact Information
Company Name	MP BIOMEDICALS DIAGNOSTICS DIVISION
Address	29525 FOUNTAIN PARKWAY
City, State, Zip	SOLON, OH 44139
Country	US
FDA Owner/Operator Phone	949-833-2500
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	LGC
FDA Classification Name	ENZYME LINKED IMMUNOABSORBENT ASSAY, HERPES SIMPLEX VIRUS, NON-SPECIFIC
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	866.3305
FDA Common Generic Name	HSV
FDA Proprietary Device Name	MULTIPLE HERPES SIMPLEX KITS
FDA Owner / Operator Number	9057708
FDA Owner / Operator Name	MP BIOMEDICALS, LLC
FDA Establishment Registration Number	2419955
FDA Registered Establishment Name	MP BIOMEDICALS DIAGNOSTICS DIVISION
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	02-22-99
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of MP BIOMEDICALS DIAGNOSTICS DIVISION

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	BIOCHECK, INC. 323 VINTAGE PARK DR. FOSTER CITY, CA 94404 US / 650-573-1968	BIOCHECK HSV-1 IGM EIA TEST KIT	HERPES SIMPLEX VIRUS-1 IGM EIA TEST KIT
2	BIO-DIAGNOSTICS LTD. UPTON INDUSTRIAL ESTATE, RECTORY RD., UPTON-UPON SEVERN WORCESTERSHIRE, WR8 OXL UK 44-168-4592262 / 44-168-4592262	BIOKITHSV-2,SURE-VUE HSV-2	HSV2 RAPID TEST
3	BIO-MEDICAL PRODUCTS CORP. 10 HALSTEAD RD. MENDHAM, NJ 07945 US 973-543-7434 / 973-543-7434
4	DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US 305-324-2300 / 305-324-2354	IS-HSV 1X2 IQG & IQM TEST KITS	HSV ELISA TESTS
5	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	MULTIPLE	HSV 1 AND ELISA KITS
6	FOCUS DIAGNOSTICS, INC. 10703 PROGRESS WAY CYPRESS, CA 90630 US 714-220-1900 / 714-220-1900 2243	MULTIPLE	VARIOUS
7	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	HSV MULTIPLE DIAGNOSIS PRODUCTS	HSV MULTIPLE DIAGNOSIS PRODUCTS
8	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 2 RESEARCH WAY PRINCETON, NJ 08540 US 781-674-3900 / 609-627-8038	HERPELISA II EIA TEST KIT	HERPESVIRUS TYPE 1 & 2 IGG ENZYME LINKED IMMUNOABSORBENT ASSAY TEST KIT
9	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229	ENZYME LINKED IMMUNOABSORBENT ASSAY, HERPES SIMPLEX VIRUS	ENZYME LINKED IMMUNOABSORBENT ASSAY, HERPES SIMPLEX VIRUS
10	QUEST INTL., INC. 1938 N.E. 148TH TERR. NORTH MIAMI, FL 33181 US 305-948-8788 / 305-948-8788	SERAQUEST HSV IGG	HERPES SIMPLEX VIRUS (HSV) SEROLOGICAL REAGENTS
11	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 HERPES I & II IGG	IMMUNOASSAY FOR THE MEASUREMENT OF HERPES I & II
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 HERPES I & II IGG	IMMUNOASSAY FOR THE MEASUREMENT OF HERPES I & II IGG
13	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851	MULTIPLE	VARIOUS TYPES - HERPES COMBINED
14	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901	HSV-1 AND-OR HSV-2 IGM ELISA TEST SYSTEM	HERPES SIMPLEX VIRUS TEST