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MULTIGENT HEMOGLOBIN CALIBRATORS
 Request for Information Form |
 Contact Information
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| Company Name | SERADYN INC. |
| Address | 7998 GEORGETOWN RD. |
| City, State, Zip | INDIANAPOLIS, IN 46268 |
| Country | US |
| FDA Owner/Operator Phone | 412-490-8425 |
| FDA Medical Specialty Code | HE - Hematology |
| FDA Product Code | KRZ |
| FDA Classification Name | CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 864.8165 |
| FDA Common Generic Name | CALIBRATOR FOR HEMOGLOBIN OR HEMATOCRIT |
| FDA Proprietary Device Name | MULTIGENT HEMOGLOBIN CALIBRATORS |
| FDA Owner / Operator Number | 2517925 |
| FDA Owner / Operator Name | FISHER SCIENTIFIC CO., LLC. |
| FDA Establishment Registration Number | 1836010 |
| FDA Registered Establishment Name | SERADYN INC. |
| FDA Operation Code(s) |
MS - Specification Developer RR - Repackager/Relabeller |
| FDA Listing Date | 04-30-04 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of SERADYN 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 | ABBOTT LABORATORIES 5440 PATRICK HENRY DR. SANTA CLARA, CA 95054 US 847-937-6100 / 847-938-3471 |
MULTIPLE | VARIOUS HEMATOLOGY CALIBRATORS |
| 2 | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263 |
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM | HEMOGLOBIN A1C PROGRAM |
| 3 | HORIBA ABX, INC. 34 BUNSEN DR. IRVINE, CA 92618 US 33-467-141516 / 949-453-0500 208 |
HAEM-CAL | MULTI-PARAMETER WHOLE BLOOD CALIBRATOR |
| 4 | MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425 |
DRI HEMOGLOBIN A1C CALIBRATORS | HEMOGLOBIN OR HEMATOCRIT MEASUREMENT CALIBRATORS |
| 5 | MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425 |
DRI HEMOGLOBIN A1C CALIBRATORS | HEMOGLOBIN OR HEMATOCRIT MEASUREMENT CALIBRATORS |
| 6 | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. MINNEAPOLIS, MN 55413 US 612-379-2956 / 800-328-2400 4413 |
HEMATOLOGY CALIBRATOR | HEMOGLOBIN CALIBRATOR |
| 7 | RADIOMETER MEDICAL APS INDUSTRIPARKEN 39-43 BALLERUP, DK-2750 DA 45-38-273827 / 45-38-273617 |
MULTIPLE | VARIOUS TYPES OF CALIBRATION SOLUTIONS |
| 8 | RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ, DK-2700 DA 45-38-273827 / 45-38-273617 |
MULTIPLE | VARIOUS TYPES OF CALIBRATION SOLUTIONS |
| 9 | ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834 |
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C | CALIBRATOR |
| 10 | SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY CARLSBAD, CA 92011 US 45-38-273827 / 45-38-273617 |
MULTIPLE | VARIOUS MODELS OF BLOOD ANALYZERS |
| 11 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
MULTIPLE | HEMOGLOBIN CALIBRATOR |
| 12 | THERMO FISHER SCIENTIFIC INC. 166 CUMMINGS CENTER BEVERLY, MA 01915 US / 978-232-6000 6095 |
SLOPE THB SOLUTION, THB CAL DYE STANDARD | THB CAL STANDARD |
| 13 | VEGAMED, INC. EDIFICIO MULTIFABRIL #5 AVE. LAS FLORES #39 VEGA BAJA, PR 00693 US 787-807-0392 / 787-807-0392 |
BRU-CALIBRATOR | CALIBRATOR FOR HEMATOCRIT AND HEMOGLOBIN |
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