HCG IRMA KIT MANUFACTURED BY NICHOLS INSTITUTE DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	NICHOLS INSTITUTE DIAGNOSTICS
Address	1311 CALLE BATIDO
City, State, Zip	SAN CLEMENTE, CA 92673
Country	US
FDA Owner/Operator Phone	949-940-7200
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	JCM
FDA Classification Name	CONTROL, HEMOGLOBIN, ABNORMAL
FDA Device Classification Code	Standards
FDA Regulation Number	864.7415
FDA Common Generic Name	HUMAN CHRONIC GONADOTROPIN IMMUNOASSAY SYSTEM
FDA Proprietary Device Name	HCG IRMA KIT
FDA Owner / Operator Number	2050095
FDA Owner / Operator Name	NICHOLS INSTITUTE DIAGNOSTICS
FDA Establishment Registration Number	2050095
FDA Registered Establishment Name	NICHOLS INSTITUTE DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-10-92
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	CANTERBURY SCIENTIFIC LTD. 14 POPE STREET CHRISTCHURCH, 8011 NZ 643-720-9625412 / 603-369-3550	HEMOGLOBIN F AND A2 CONTROL (BETA-THALASSAEMIA CONTROL)	ABNORMAL HEMOGLOBIN CONTROL
2	DIAGNOSTIC TECHNOLOGY, INC. 175 COMMERCE DR. UNIT L HAUPPAUGE, NY 11788 US 631-582-4949 / 631-582-4949	SICKLE-CHECK TM	SICKLE CELL HEMAGLOBIN CONTROL FOR TESTING PRESENCE OF HEMOGLOBIN S
3	PRIMUS CORP. 4231 E. 75TH TERRACE KANSAS CITY, MO 64132 US 353-127-69800 / 816-523-7491	CONTROLS FOR ABNORMAL HEMOGLOBINS	FASC CONTROL, A2, F CONTROL