GAMMA-B 25-HYDROXY VITAMIN D RIA MANUFACTURED BY IMMUNODIAGNOSTIC SYSTEMS LTD.

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Request for Information Form	Contact Information
Company Name	IMMUNODIAGNOSTIC SYSTEMS LTD.
Address	10 DIDCOT WAY, BOLDEN BUSINESS PARK
City, State, Zip	BOLDON, TYNE & WEAR,
Country	UK
FDA Owner/Operator Phone	+44-191-519-0660
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	MRG
FDA Classification Name	SYSTEM, TEST, VITAMIN D
FDA Device Classification Code	Standards
FDA Regulation Number	862.1825
FDA Common Generic Name	25-HYDROXYVITAMIN D RIA KIT
FDA Proprietary Device Name	GAMMA-B 25-HYDROXY VITAMIN D RIA
FDA Owner / Operator Number	8021924
FDA Owner / Operator Name	IMMUNODIAGNOSTIC SYSTEMS LTD.
FDA Establishment Registration Number	8021924
FDA Registered Establishment Name	IMMUNODIAGNOSTIC SYSTEMS LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-21-00
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	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	INCSTAR 25-HYDROXYVITAMIN D125 I RIA KIT	25-HYDROXYVITAMIN D RIA
2	NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO SAN CLEMENTE, CA 92673 US 949-940-7200 / 949-940-7465	NICHOLS ADVANTAGE CHEMILUMINESCENCE 25-OH VITAMIN D IMMUNOASAY	25-OH VIT D