ACCUTEX SLE LATEX KITS MANUFACTURED BY NERL DIAGNOSTICS LLC.

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ACCUTEX SLE LATEX KITS

Request for Information Form	Contact Information
Company Name	NERL DIAGNOSTICS LLC.
Address	14 ALMEIDA AVE.
City, State, Zip	EAST PROVIDENCE, RI 02914
Country	US
FDA Owner/Operator Phone	412-490-8425
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	DHC
FDA Classification Name	SYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS
FDA Device Classification Code	Standards
FDA Regulation Number	866.5820
FDA Common Generic Name	SLE LATEX KITS
FDA Proprietary Device Name	ACCUTEX SLE LATEX KITS
FDA Owner / Operator Number	2517925
FDA Owner / Operator Name	FISHER SCIENTIFIC CO., LLC.
FDA Establishment Registration Number	1215667
FDA Registered Establishment Name	NERL DIAGNOSTICS LLC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-31-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of NERL DIAGNOSTICS LLC.

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	ARLINGTON SCIENTIFIC, INC. 1840 NORTH TECHNOLOGY DR. SPRINGVILLE, UT 84663 US 801-489-8911 / 801-489-8911	SLE SLIDE TEST	SYSTEMIC LUPUS ERYTHEMATOSUS IMMUNOLOGICAL TEST
2	BIO-MEDICAL PRODUCTS CORP. 10 HALSTEAD RD. MENDHAM, NJ 07945 US 973-543-7434 / 973-543-7434
3	CORGENIX, INC. 11575 MAIN ST. SUITE 400 BROOMFIELD, CO 80020 US 303-457-4345 / 303-457-4345 130	REAADS IGA ANTI B26P1 TEST KIT	REAADS IGA ANTI B26P1 TEST KIT
4	DIAGNOSTICA STAGO 23/29 RUE CONSTANTIN PECQUER TAVERNY, 95150 FR 33-146-88 20 20 / 33-146-854851	PTT-LA, STACLOT LA	REAGENTS FOR THE DETECTION OF LUPUS ANTICOAGULANTS
5	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	PTT-LA, STACLOT LA	REAGENTS FOR THE DETECTION OF LUPUS ANTICOAGULANTS
6	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	GLOBALEMED SLE LATEX TEST	SLE LATEX TESTS
7	IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D SACRAMENTO, CA 95827 US 916-363-2649 / 916-363-2649	SS-A/SS-B AUTO I.D.(R) AUTOANTIBODY TEST SYSTEM	ENA (EXTRACTABLE NUCLEAR ANTIGEN) TEST
8	IMMUNOSTICS, INC. 3505 SUNSET AVE. OCEAN, NJ 07712 US / 732-918-0770	IMMUNO/SLE	LATEX SLIDE AGGLUTINATION TEST FOR THE DETECTION OF LUPUS SYNDROME
9	MEDICA, INC. 336 ENCINITAS BLVD., SUITE 200 ENCINITAS, CA 92024 US 760-634-5440 / 760-634-5440	MEDICA IIF-A-NDNA-A TEST KIT	INDIRECT IMMUNOFLUORESCENCE ANTI-NATIVE DEOXYRIBONUCLEIC ACID TEST KIT
10	PRECISA INTL. CORP. 4890 S.W. 74TH CT. MIAMI, FL 33155 US 305-669-0895 / 305-669-0898	IMMUNO-SLE	KIT FOR THE DETECTION OF SYSTEMIC LUPUS ERYTEMATOSUS
11	PULSE SCIENTIFIC, INC. 5100 SOUTH SERVICE RD., UNIT 18 BURLINGTON, ONTARIO, L7L 6A5 CA 905-333-8188 / 800-363-7907	PULSE SLE TEST	SLE TEST
12	R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. SOUTH BEND, IN 46628 US 574-288-4377 / 574-288-4377	LUPOTEK DETECTIN, CORRECTIN	LUPOTEK DETECTIN, CORRECTIN
13	SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL SAN ANTONIO, TX 78240 US 210-699-8800 / 210-699-8800 202	SAS SLE TEST	SYSTEMIC LUPUS ERYTHEMATOSUS TEST
14	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	NO PROPRIETARY NAME LISTED	LE TEST REAGENT KIT
15	STERLING DIAGNOSTICS, INC. 36645 METRO COURT STERLING HEIGHTS, MI 48312 US 810-979-9171 / 810-979-2141		LUPUS ERYTHEMATOSUS REAGENT SET
16	TEXAS IMMUNOLOGY, INC. 12524 FM 3226 TYLER, TX 75707 US 903-566-6696 / 903-566-6696	SERO/TEX LE TEST	SYSTEMIC LUPUS ERYTHEMATOSUS IMMUNOLOGICAL TEST SYSTEM
17	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	DS DNA EIA KIT	DS DNA EIA KIT
18	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901	ANTI-DEOXYRIBONUCLEIC ACID (ADNA) TEST KIT	DNA IFA KIT