CRYPTO-LEX MANUFACTURED BY REMEL ATLANTA, A DIV. OF REMEL, INC.

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Request for Information Form	Contact Information
Company Name	REMEL ATLANTA, A DIV. OF REMEL, INC.
Address	2797 PETERSON PL.
City, State, Zip	NORCROSS, GA 30071
Country	US
FDA Owner/Operator Phone	412-490-8425
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	GMD
FDA Classification Name	ANTISERA, LATEX AGGLUTINATION, CRYPTOCOCCUS NEOFORMANS
FDA Device Classification Code	Standards
FDA Regulation Number	866.3165
FDA Common Generic Name	CRYPTO-LEX SYSTEM
FDA Proprietary Device Name	CRYPTO-LEX
FDA Owner / Operator Number	2517925
FDA Owner / Operator Name	FISHER SCIENTIFIC CO., LLC.
FDA Establishment Registration Number	1031428
FDA Registered Establishment Name	REMEL ATLANTA, A DIV. OF REMEL, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-31-01
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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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	IMMUNO-MYCOLOGICS, INC. 2700 TECHNOLOGY PLACE NORMAN, OK 73071 US 405-360-4669 / 405-360-4669	YA-CRYPTO CRYPTOCOCCUS ANTIBODY TEST	CRYPTOCOCCUS ANTIBODY TEST
2	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 2 RESEARCH WAY PRINCETON, NJ 08540 US 781-674-3900 / 609-627-8038	CRYPTO-LA TEST	CRYPTO-LA TEST
3	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229	CALAS (CRYPTOCOCAL ANTIGEN LATEX AGGLUTINATION TEST)	LATEX AGGLUTINATION ASSAY FOR C. NEOFORMANS