T-4 MAIA RIA KIT (MULTIPLE BRANDS) MANUFACTURED BY ADALTIS S.P.A. DIAGNOSTICS PLANT

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T-4 MAIA RIA KIT (MULTIPLE BRANDS)

Request for Information Form	Contact Information
Company Name	ADALTIS S.P.A. DIAGNOSTICS PLANT
Address	VIA LUIGI EINAUDI, 7
City, State, Zip	GUIDONIA MONTECELIO, ROMA,
Country	IT
FDA Owner/Operator Phone	514-335-9922
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CDX
FDA Classification Name	RADIOIMMUNOASSAY, TOTAL THYROXINE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1700
FDA Common Generic Name	T-4 RADIOIMMUNOASSAY
FDA Proprietary Device Name	T-4 MAIA RIA KIT (MULTIPLE BRANDS)
FDA Owner / Operator Number	9011134
FDA Owner / Operator Name	ADALTIS INC.
FDA Establishment Registration Number	9680066
FDA Registered Establishment Name	ADALTIS S.P.A. DIAGNOSTICS PLANT
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	10-19-01
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ADALTIS S.P.A. DIAGNOSTICS PLANT

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	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	MULTIPLE:IMX, AXSYM, ARCHITECT T4	VARIOUS T4 OR THYROXINE ASSAYS
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE:IMX, AXSYM, ARCHITECT T4	VARIOUS T4 OR THYROXINE ASSAYS
3	ANTIBODIES INC. 25242 CR 95 DAVIS, CA 95616 US 530-758-4400 / 530-758-4400	125-I - T4-SECOND ANTIBODY BUFFER SYSTEM	T4 RIA KIT
4	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	VARIOUS
5	BIOMERICA, INC. 1533 MONROVIA AVE. NEWPORT BEACH, CA 92663 US 949-645-2111 / 949-645-2111 330	T-4 (RIA) KIT RIA METHOD FOR DETERMINATION OF SERUM THRYOXIN	T-4 (RIA) KIT RIA METHOD FOR DETERMINATION OF SERUM THRYOXINE
6	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	THYROXINE (T4) BY RADIOIMMUNOASSAY	T4 RIA KIT
7	MONOBIND, INC. 100 N. POINTE DR. LAKE FOREST, CA 92630 US 949-951-2665 / 949-951-2665		T4 RADIOIMMUNOASSAY TEST SYSTEM
8	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	T 4 SOLID PHASE RADIOIMMUNOASSAY KIT 125 I	T 4 SOLID PHASE RADIOIMMUNOASSAY KIT 125 I
9	NEOMETRICS, A DIVISION OF NATUS 104 BELLEROSE AVE. EAST NORTHPORT, NY 11731 US 516-754-8080 / 516-754-8080	ACCUSCREEN TY
10	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834	CEDIA T4	TOTAL THYROXIDINE TEST
11	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	ENZYMUN TEST T4	ENZYMUN TEST T4 (ENZYME IMMUNE ASSAY)
12	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS T4 ASSAY	T4 ASSAY
13	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
14	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	COAT-A-COUNT NEONATAL T4, TOTAL T4	RADIOIMMUNOASSAY FOR MEASUREMENT OF THYROXINE (T4)
15	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	COAT-A-COUNT NEONATAL T4, TOTAL T4	RADIOIMMUNOASSAY FOR MEASUREMENT OF THYROXINE (T4)
16	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	MULTIPLE	TOTAL THYROXINE
17	TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909	AIA-PACK T4, ST AIA-PACK T4	TOTAL THYROXINE TEST SYSTEM
18	TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909	AIA-PACK T4, ST AIA-PACK T4	TOTAL THYROXINE TEST SYSTEM
19	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851	VARIOUS TYPES OF T4 KITS	VARIOUS TYPES OF T4 KITS
20	WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111	MULTIPLE	FLUOROIMMUNOASSAY FOR THE DETERMINATION OF THYROXINE