FDA Registered Microbiology Medical Devices List: ANTIGENS, IF, TOXOPLASMA GONDII

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Medical Specialty: Microbiology
Classification: ANTIGENS, IF, TOXOPLASMA GONDII

	Common Generic Device Name	Proprietary Device Name	Company
1	IFA TOXOPLASMA TEST KIT	IFA TOXOPLASMA TEST KIT	AMICO LAB, INC. 5012 ILLINOIS AVE. 5012 ILLINOIS AVE. NASHVILLE, TN 37209 US 615-385-7711 / 615-385-7711
2	ENZYME-LINKED DOT-BLOT IMMUNOASSAY-TOXOPLASMA	IMMUNODOT T.E.C.H. TEST	GENBIO 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US 858-592-9300 309 / 858-592-9300 309
3	VARIOUS ASSAYS FOR THE DIAGNOSTICS OF T. GONDII INFECTION	MULTIPLE: MERIFLUOR TOXOPLASMA IGG IFA AND MERIFLUOR	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229
4	TOXOPLASMA GONDII IGM IFA TEST SYSTEM	TOXOPLASMA GONDII IGM IFA TEST SYSTEM	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901
5	TOXO IFA	VIRGO TOXO IGG IFA	HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501

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

Grant# R44AI048315-03
CORIXA CORPORATION

Grant# R44AI048315-02
CORIXA CORPORATION

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

Grant# R43CA102862-02
INSERT THERAPEUTICS, INC.

Grant# R43CA102862-01
INSERT THERAPEUTICS, INC.

Grant# R41CA101542-01A1
L2 DIAGNOSTICS, LLC

Grant# R41CA106107-01
L2 DIAGNOSTICS, LLC

Grant# R43CA101609-01A1
LIFETIME PHARMACEUTICAL, INC.

Grant# R43CA101287-01
MACROGENICS, INC.

Grant# R43CA095929-02
MIRUS CORPORATION

Grant# R43AI055227-01A1
PEPGEN CORPORATION

Grant# R41HL076964-01
TRANSGENEX THERAPEUTICS

Grant# R43CA108032-01
VACCINEX, INC.