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

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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	CIB
FDA Classification Name	RADIOIMMUNOASSAY, ANGIOTENSIN I AND RENIN
FDA Device Classification Code	Standards
FDA Regulation Number	862.1085
FDA Common Generic Name	RENIN/ANGIOTENSIN RADIOIMMUNOASSAY KIT
FDA Proprietary Device Name	RENIN 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

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	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	RADIOIMMUNOASSAY, ANGIOTENSIN I AND RENIN	RADIOIMMUNOASSAY, ANGIOTENSIN I AND RENIN
2	BUHLMANN LABORATORIES AG BASELSTRASSEE 55 SCHONENBUCH/BASEL, CH-4124 SZ 41- 61-487 12 12 / 603-893-8914	BUHLMANN ANGIOTENSIN II RIA	ANGIOTENSIN II RIA
3	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	GAMMACOAT (125-I) PLASMA RENIN ACTIVITY RADIOIMMUNOASSAY KIT	RIA KITS FOR DETERMINATION OF PLASMA RENIN ACTIVITY
4	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	RADIOIMMUNOASSAY, ANGIOTENSIN I AND RENIN	RADIOIMMUNOASSAY, ANGIOTENSIN I AND RENIN
5	IMMUNO-DIAGNOSTIC LAB & PRODUCTS 515 S.BEACH BLVD. ANAHEIM, CA 92804 US / 714-992-6499	ANGIOTENSIN CONVERTING ENZYME (SACE)	ANGIOTENSIN CONVERTING ENZYME (SACE)
6	NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO SAN CLEMENTE, CA 92673 US 949-940-7200 / 949-940-7465	MULTIPLE	MULTIPLE