FDA Registered Microbiology Medical Devices List: ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS

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Medical Specialty: Microbiology
Classification: ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS

	Common Generic Device Name	Proprietary Device Name	Company
1	ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS	ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229
2	EBV IGM TEST SYSTEM	ATHENA MULTI-LYTE(R) EBV VCA IGM TEST SYSTEM	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901
3	EPSTEIN-BARR VIRUS IVD (IGM)	COPALIS EBV-M ANTIBODY ASSAY	DIASORIN, INC. 1951 NORTHWESTERN AVE. 1951 NORTHWESTERN AVE. STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820
4	ELISA EBV IGM TEST KIT	EBV IGM	AMICO LAB, INC. 5012 ILLINOIS AVE. 5012 ILLINOIS AVE. NASHVILLE, TN 37209 US 615-385-7711 / 615-385-7711
5	EPSTEIN-BARR VIRUS IGM ANTIBODY DETECTION BY IFA TESTS	EBV-M IFA TEST SYSTEM	BION ENTERPRISES, LTD. 455 STATE STREET, 455 STATE STREET, DES PLAINES, IL 60016 US 847-544-5044 / 847-544-5044
6	IMMUNOWELL EBV VCA IGM TEST	IMMUNOWELL EBV VCA IGM TEST	GENBIO 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US 858-592-9300 309 / 858-592-9300 309
7	ANTI-EB VCA IGM SEROLOGICAL REAGENTS, ELISA	SERAQUEST EB VCA IGM	QUEST INTL., INC. 1938 N.E. 148TH TERR. NORTH MIAMI, FL 33181 US 305-948-8788 / 305-948-8788

The following companies have received SBIR/SBTT awards that may be related to these products. Click on the listings below for more details.

Grant# R44NS043829-02A1
ICHOR MEDICAL SYSTEMS, INC.

Grant# R43CA102862-02
INSERT THERAPEUTICS, INC.

Grant# R43CA102862-01
INSERT THERAPEUTICS, INC.

Grant# R43CA101609-01A1
LIFETIME PHARMACEUTICAL, INC.

Grant# R43CA101287-01
MACROGENICS, INC.

Grant# R43AI055227-01A1
PEPGEN CORPORATION

Grant# R41HL076964-01
TRANSGENEX THERAPEUTICS