QTEST PREGNANCY, DIRECTIGEN hCG PREGNANCY TEST, RAMP MANUFACTURED BY QUIDEL CORP.

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QTEST PREGNANCY, DIRECTIGEN hCG PREGNANCY TEST, RAMP

Request for Information Form	Contact Information
Company Name	QUIDEL CORP.
Address	10165 MCKELLAR CT.
City, State, Zip	SAN DIEGO, CA 92121
Country	US
FDA Owner/Operator Phone	858-552-1100
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JHJ
FDA Classification Name	AGGLUTINATION METHOD, HUMAN CHORIONIC GONADOTROPIN
FDA Device Classification Code	Standards
FDA Regulation Number	862.1155
FDA Common Generic Name	HUMAN CHORIONIC GONADOTROPIN TEST SYSTEMS
FDA Proprietary Device Name	QTEST PREGNANCY, DIRECTIGEN hCG PREGNANCY TEST, RAMP
FDA Owner / Operator Number	2024674
FDA Owner / Operator Name	QUIDEL CORP.
FDA Establishment Registration Number	2024674
FDA Registered Establishment Name	QUIDEL CORP.
FDA Operation Code(s)	ME - Contract Manufacturer MM - Manufacturer
FDA Listing Date	12-22-92
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of QUIDEL CORP.

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	APPLIED BIOTECH 10237 FLANDERS CT. SAN DIEGO, CA 92121 US 781-674-3900 / 858-587-6771	PREGSLIDE, PREGNANCY TEST	HCG PREGNANCY TEST, LATEX AGGLUTINATION
2	BIO-MEDICAL PRODUCTS CORP. 10 HALSTEAD RD. MENDHAM, NJ 07945 US 973-543-7434 / 973-543-7434
3	BIOMERICA, INC. 1533 MONROVIA AVE. NEWPORT BEACH, CA 92663 US 949-645-2111 / 949-645-2111 330	NUMBUS NMS 1043 EIA ENZYME IMMUNOASSAY COLORMETRIC	QUALITATIVE DETERMINATION OF HCG IS SERUM OR URINE
4	BOEHRINGER BIOCHEMIA ROBIN S.P.A. VIALE LIBERTA KM 0.750 MONZA, 20052 IT	MULTIPLE	IMMUNOLOGIC PREGNANCY TUBE TEST
5	CANWEST MEDICTEX, INC. 3588 VALLEY DR. VANCOUVER B.C., CA 604--6817757 / 604--6817757	CANWEST-PREGBLUE	CANWEST-PREGBLUE
6	CTK BIOTECH, INC. 6748 NANCY RIDGE DR. SAN DIEGO, CA 92121 US 858-457-8698 / 858-457-8698	HCG URINE ONSITE RAPID SCREENING KIT, CASSETTE, DIP-STICKER	VARIOUS HCG RAPID TEST KITS OR HCG EARLY PRENANCY TEST KITS, CASSETTE, DIP-STICK
7	DIAGNOSTIC SPECIALTIES 4 LEONARD ST. METUCHEN, NJ 08840 US 732-549-4011 / 732-549-4011	PREGNA CERT LATEX PREGNANCY KIT	LATEX PREGNANCY TEST SET
8	EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605	MULTIPLE	VARIOUS
9	EIKEN CHEMICAL CO., LTD. 1-33-8, HONGO BUNKYO-KU, TOKYO, 113-8408 JA 81-33-8134888 / 81-33-8134888	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
10	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
11	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	GLOBALEMED PREGNANCY LATEX TEST	HCG PREGNANCY LATEX TESTS
12	IMMUNOSTICS, INC. 3505 SUNSET AVE. OCEAN, NJ 07712 US / 732-918-0770	IMMUNO/CEPT- DIRECT MONOCLONAL	DIRECT 2 MINUTE LATEX SLIDE AGGLUTINATION TEST FOR HCG 0.3 IU.ML
13	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 2 RESEARCH WAY PRINCETON, NJ 08540 US 781-674-3900 / 609-627-8038	UGC-SLIDE TEST	HUMAN CHORONIC GONADOTROPIN TEST
14	PRECISA INTL. CORP. 4890 S.W. 74TH CT. MIAMI, FL 33155 US 305-669-0895 / 305-669-0898	PRECISA ONE STEP MIDSTREAM, PRECISA ONE STEP CARD, PRECISA ONE STEP STRIP	PREGNANCY TEST
15	PULSE SCIENTIFIC, INC. 5100 SOUTH SERVICE RD., UNIT 18 BURLINGTON, ONTARIO, L7L 6A5 CA 905-333-8188 / 800-363-7907	PULSE PREGNANCY TEST	AGGLUTINATION METHOD, HUMAN CHORIONIC GONADOTROPIN
16	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834	HUMAN CHORIONIC GONADOTROPIN	HCG
17	SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL SAN ANTONIO, TX 78240 US 210-699-8800 / 210-699-8800 202	SAS HCG URINE CONTROLS	PREGNANCY TEST CONTROLS
18	SCIMEDX CORP. 400 FORD RD. DENVILLE, NJ 07834 US 973-625-8822 20 / 201-625-8822	AGGLUTINATION METHOD, HUMAN CHORIONIC GONADOTROPIN	AGGLUTINATION METHOD, HUMAN CHORIONIC GONADOTROPIN
19	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
20	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	MAGIC LITE (HCG) COMBINATION SOLID PHASE, LITE REAGENT	REAGENT
21	TANABE U.S.A., INC. 5175 W. DIABLO DR., SUITE 105 LAS VEGAS, NV 89118 US 858-571-8410 / 858-571-8410	GESTATE SLIDE	PREGNANCY TEST SLIDE
22	TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788	MONOCLONAL B-HCG PREGNANCY TEST (INDIRECT)	MONOCLONAL B-HCG PREGNANCY TEST (INDIRECT)
23	TEXAS IMMUNOLOGY, INC. 12524 FM 3226 TYLER, TX 75707 US 903-566-6696 / 903-566-6696	V-TREND BETA-HCG DRY SPOT TEST, PREG/TEX PREGNANCY TEST, V-TREND BETA HCG TEST	HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM
24	TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909	AIA-APCK HCG	HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM