BIOMERICA IMPACT-PTH ELISA KIT MANUFACTURED BY BIOMERICA, INC.

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BIOMERICA IMPACT-PTH ELISA KIT

Request for Information Form	Contact Information
Company Name	BIOMERICA, INC.
Address	1533 MONROVIA AVE.
City, State, Zip	NEWPORT BEACH, CA 92663
Country	US
FDA Owner/Operator Phone	949-645-2111
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CEW
FDA Classification Name	RADIOIMMUNOASSAY, PARATHYROID HORMONE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1545
FDA Common Generic Name	PARATHYROID HORMONE IN SERUM
FDA Proprietary Device Name	BIOMERICA IMPACT-PTH ELISA KIT
FDA Owner / Operator Number	2016793
FDA Owner / Operator Name	BIOMERICA, INC.
FDA Establishment Registration Number	2016793
FDA Registered Establishment Name	BIOMERICA, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-01-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of BIOMERICA, INC.

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	MULTIPLE	VARIOUS
2	BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000	ARCHITECT INTACT PTH	CHEMILUMINESCENT PTH REAGENT
3	CHISOLM BIOLOGICAL LABORATORY 542 LEGION RD. WARRENVILLE, SC 29851 US 803-663-9618 / 803-663-9618	PARATHYROID HORMONE ANALYSIS PRODUCTS	PARATHYROID HORMONE (PTH) ANTIBODY
4	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	HUMAN PARATHYROID HORMONE (PEH) BY RADIOIMMUNOASSAY	PTH RIA KIT
5	FUTURE DIAGNOSTICS B.V. NIEUWEWEG 172 6603 BT WYCHEN, 6603 BT NL 310-246-452900 / 312-464-52900	STAT-INTRAOPERATIVE INTACT PTH TEST SYSTEM	STAT-INTRAOPERATIVE INTACT
6	IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK BOLDON, TYNE & WEAR, NE35 9PD UK +44-191-519-0660 / 44-191-5190660	MULTIPLE	INTACT PTH IMMUNOASSAY KITS
7	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	PTH INTACT RADIOIMMUNOASSAY COATED TUBE	PTH INTACT RADIOIMMUNOASSAY COATED TUBE
8	NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO SAN CLEMENTE, CA 92673 US 949-940-7200 / 949-940-7465	NICHOLAS ADVANTAGE CHEMILUMINESCENCE BIOINTACT PTH (1-84)	PARATHYROID HORMONE (1-84)
9	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS PARATHYROID HORMONE TEST SYSTEM	PTH ASSAY
10	SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY SANTEE, CA 92071 US 619-258-9300 / 619-258-9300 450	SCANTIBODIES LABORATORY PTH IRMA KIT	PTH IRMA KIT
11	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 2000, IML 2500, IML TURBO PTH (INTACT)	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF INTACT PTH
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	BAYER DIAGNOSTICS ACS:180 & ADVIA CENTAUR INTACT PTH ASSAY	PARATHYROID HORMONE ASSAY
13	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 2000, IML 2500, IML TURBO PTH (INTACT)	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF INTACT PTH
14	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	BAYER DIAGNOSTICS ACS:180 & ADVIA CENTAUR INTACT PTH ASSAY	PARATHYROID HORMONE ASSAY