TB FLUOROSTAIN KIT MANUFACTURED BY POLYSCIENCES, INC.

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Request for Information Form	Contact Information
Company Name	POLYSCIENCES, INC.
Address	400 VALLEY RD.
City, State, Zip	WARRINGTON, PA 18976
Country	US
FDA Owner/Operator Phone	215-343-6484
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	JSY
FDA Classification Name	KIT, IDENTIFICATION, MYCOBACTERIA
FDA Device Classification Code	General Controls
FDA Regulation Number	866.2660
FDA Common Generic Name	STAINING KIT FOR THE IDENTIFICATION FO MYCOBACTERIA
FDA Proprietary Device Name	TB FLUOROSTAIN KIT
FDA Owner / Operator Number	2518071
FDA Owner / Operator Name	POLYSCIENCES, INC.
FDA Establishment Registration Number	2518071
FDA Registered Establishment Name	POLYSCIENCES, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	05-03-93
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	ACCESS BIO INCORPORATE 2033 RT. 130 UNIT H MONMOUTH JUNCTION, NJ 08852 US 732-297-2222 / 732-297-2222 103	CARESTART TUBERCULOSIS TEST	TUBERCULOSIS TEST
2	BECTON, DICKINSON & CO. 7 LOVETON CIR. SPARKS, MD 21152 US 201-847-6800 / 410-316-4000 4099	MULTIPLE	BD PROBETEC MYCOBACTERIA ID
3	FORMOSA BIOMEDICAL TECHNOLOGY CORP. F-5F, NO.201, TUNGHUA N. RD TAIPEI, 105 TW 886-227-122211 / 886-227-122211	MEDIPRO M. TUBERCULOSIS ANTIGEN RAPID TEST	KIT, IDENTIFICATION, MYCOBACTERIA
4	GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 US 858-410-8000 / 858-410-8891	ACCUPROBE MYCOBACTERIUM KANSASII CULTURE ID TEST	ACCUPROBE MYCOBACTERIUM KANSASII CULTURE ID TEST
5	IMMUNOSCIENCE, INC. 7066-D COMMERCE CIR. PLEASANTON, CA 94588 US / 925-460-8111	SALIVAX-TB	MYCOBACTERIUM TUBERCULOSIS ASSAY
6	M&D INC. 210 YWBI, 234 MAEJI-RI HEUNGUP-MYUN WONJU-SI, GANGWON-DO, KS / 267-210-9365	MYCO-ID, NEW MTB-ID, TB-TAG	MICRO ORGANISM DIFFERENTIATION AND IDENTIFICATION DEVICE