REACTIVE AND NONREACTIVE(ART) CONTROL SERUM MANUFACTURED BY BECTON DICKINSON CARIBE LTD.

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Request for Information Form	Contact Information
Company Name	BECTON DICKINSON CARIBE LTD.
Address	VICKS DR., LOT #6
City, State, Zip	CAYEY, PR 00634
Country	US
FDA Owner/Operator Phone	201-847-6800
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	GMP
FDA Classification Name	ANTISERA, CONTROL FOR NONTREPONEMAL TESTS
FDA Device Classification Code	Standards
FDA Regulation Number	866.3820
FDA Common Generic Name	CONTROL SERA FOR AUTOMATED REAGIN TEST FOR SYPHILLIS
FDA Proprietary Device Name	REACTIVE AND NONREACTIVE(ART) CONTROL SERUM
FDA Owner / Operator Number	9922032
FDA Owner / Operator Name	BECTON, DICKINSON & CO.
FDA Establishment Registration Number	2647876
FDA Registered Establishment Name	BECTON DICKINSON CARIBE LTD.
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date
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	CENOGENICS CORP. 100 RT. 520 MORGANVILLE, NJ 07751 US 732-536-6457 / 732-536-6457	VDRL (REACTIVE, WEAKLY REACTIVE, NONREACTIVE) CONTROL SERUM	STS
2	IMMUNOSTICS, INC. 3505 SUNSET AVE. OCEAN, NJ 07712 US / 732-918-0770	TEST KIT	SYPHILIS CONTROLS
3	NEW HORIZONS DIAGNOSTICS CORP. 9110 RED BRANCH RD., STE. B COLUMBIA, MD 21045 US 410-992-9357 / 410-992-9357 222	TRUST CONTROLS	TRUST SYPHILLIS SEROLOGICAL REAGENT CONTROUS
4	NEWMARKET LABORATORIES LTD. LANWADES BUSINESS PARK, KENTFORD NEWMARKET, CB8 7PN UK 441-638-552882 / 441-638-552882	RPR CONTROL	RPR CONTROL
5	REMEL ATLANTA, A DIV. OF REMEL, INC. 2797 PETERSON PL. NORCROSS, GA 30071 US 412-490-8425 / 412-490-8425	MULTIPLE	MULTIPLE
6	SCIMEDX CORP. 400 FORD RD. DENVILLE, NJ 07834 US 973-625-8822 20 / 201-625-8822	ANTISERA, CONTROL FOR NONTREPONEMAL TESTS	ANTISERA, CONTROL FOR NONTREPONEMAL TESTS
7	TEXAS IMMUNOLOGY, INC. 12524 FM 3226 TYLER, TX 75707 US 903-566-6696 / 903-566-6696	V-TREND RPRL CARD TEST	TREPONEMAL PALLIDIUM NON-TREPONEMAL TEST REAGENTS