IMMUCHEM ACTH DOUBLE ANTIBODY MANUFACTURED BY MP BIOMEDICALS DIAGNOSTICS DIVISION

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Request for Information Form	Contact Information
Company Name	MP BIOMEDICALS DIAGNOSTICS DIVISION
Address	29525 FOUNTAIN PARKWAY
City, State, Zip	SOLON, OH 44139
Country	US
FDA Owner/Operator Phone	949-833-2500
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CKG
FDA Classification Name	RADIOIMMUNOASSAY, ACTH
FDA Device Classification Code	Standards
FDA Regulation Number	862.1025
FDA Common Generic Name	PROCEDURE FOR THE RIA OF ADRENOCORTICOTROPIC HORMONE
FDA Proprietary Device Name	IMMUCHEM ACTH DOUBLE ANTIBODY
FDA Owner / Operator Number	9057708
FDA Owner / Operator Name	MP BIOMEDICALS, LLC
FDA Establishment Registration Number	2419955
FDA Registered Establishment Name	MP BIOMEDICALS DIAGNOSTICS DIVISION
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	07-11-96
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, ACTH	RADIOIMMUNOASSAY, ACTH
2	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	ADRENOCORTICOTROPIC HORMONE BY RADIOIMMUNOASSAY	ACTH RIA KIT
3	NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO SAN CLEMENTE, CA 92673 US 949-940-7200 / 949-940-7465	MULTIPLE	MULTIPLE
4	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS ACTH TEST SYSTEM	ACTH TEST SYSTEM
5	SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY SANTEE, CA 92071 US 619-258-9300 / 619-258-9300 450	ACTH IMMUNORADIOMETRIC(IRMA)DIAGNOSTIC ASSAY KIT	ACTH IRMA
6	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 ACTH	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF ACTH
7	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 ACTH	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF ACTH
8	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 ACTH	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF ACTH