VIRGO CMV IGM IFA MANUFACTURED BY HEMAGEN DIAGNOSTICS, INC.

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Request for Information Form	Contact Information
Company Name	HEMAGEN DIAGNOSTICS, INC.
Address	9033 RED BRANCH RD.
City, State, Zip	COLUMBIA, MD 21045
Country	US
FDA Owner/Operator Phone	800-436-2436
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	LKQ
FDA Classification Name	ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS
FDA Device Classification Code	Standards
FDA Regulation Number	866.3175
FDA Common Generic Name	CMV IFA
FDA Proprietary Device Name	VIRGO CMV IGM IFA
FDA Owner / Operator Number	1221107
FDA Owner / Operator Name	HEMAGEN DIAGNOSTICS, INC.
FDA Establishment Registration Number	1181055
FDA Registered Establishment Name	HEMAGEN DIAGNOSTICS, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	07-09-95
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	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS
2	BBI DIAGNOSTICS, A DIVISION OF SERACARE LIFE SCIEN 375 WEST ST. WEST BRIDGEWATER, MA 02379 US 508-580-1900 / 508-580-1900 2175	ACCURUN 146 CMV IGM POSITIVE CONTROL, CLASS II	ACCURUN 146 CMV IGM POSITIVE CONTROL
3	BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594	VIDAS CMV IGM ASSAY	ENZYME-LINKED FLUORESCENT IMMUNOASSAY CMV IGM
4	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594	VIDAS CMV IGM ASSAY	ENZYME-LINKED FLUORESCENT IMMUNOASSAY CMV IGM
5	IMMUCOR, INC. 3130 GATEWAY DR. P.O. BOX 5625 NORCROSS, GA 30091 US 770-441-2051 / 770-441-2051 5304	CAPTURE - CMV	CMV ANTIBODY DETECTION TEST
6	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229	ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS	ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS
7	MILLIPORE CORPORATION 28820 SINGLE OAK DR. TEMECULA, CA 92590 US 978-715-1399 / 978-715-1399	MULTIPLE	VARIOUS
8	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901	CMV IGM IFA TEST SYSTEM	CMV IGM TEST SYSTEM