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TINA-QUANT IGG GEN2
 Request for Information Form |
 Contact Information
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| Company Name | ROCHE DIAGNOSTICS GMBH |
| Address | NONNENWALD 2 |
| City, State, Zip | PENZBERG, |
| Country | GM |
| FDA Owner/Operator Phone | 49-621-7670 |
| FDA Medical Specialty Code | IM - Immunology |
| FDA Product Code | DEW |
| FDA Classification Name | IGG, ANTIGEN, ANTISERUM, CONTROL |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 866.5510 |
| FDA Common Generic Name | IMMUNOGLOBULIN TEST |
| FDA Proprietary Device Name | TINA-QUANT IGG GEN2 |
| FDA Owner / Operator Number | 9036646 |
| FDA Owner / Operator Name | ROCHE DIAGNOSTICS GMBH MANNHEIM |
| FDA Establishment Registration Number | 9610529 |
| FDA Registered Establishment Name | ROCHE DIAGNOSTICS GMBH |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 01-24-05 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of ROCHE DIAGNOSTICS GMBH
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 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471 |
IG G | IMMUNOGLOBULIN G |
| 2 | BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | IGG CALIBRATOR/CONTROL |
| 3 | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383 |
QUANTIPLATE OR ENDOPLATE TM IGG SINGLE RADIAL IMMUNODIFFUSIO | IGG SINGLE RADIAL IMMUNODIFFUSION KIT |
| 4 | BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383 |
MULTIPLE | IGG CALIBRATOR/CONTROL |
| 5 | BIOMERIEUX ITALIA-INDUSTRIAL DIV. VIA DI CAMPIGLIANO 58 PONTE-A EMA, FLORENCE, 50015 IT 33-478-872063 / 314-731-8594 |
VITEK IMMUNO DIAGNOSTIC ASSAY SYSTEM (VIDAS) | DISCRETE WAVELENGTH FLUOROMETER |
| 6 | BIOMERIEUX, INC. 100 RODOLPHE ST DURHAM, NC 27712 US 33-478-872063 / 314-731-8594 |
VITEK IMMUNO DIAGNOSTIC ASSAY SYSTEM (VIDAS) | DISCRETE WAVELENGTH FLUOROMETER |
| 7 | BIT ANALYTICAL INSTRUMENTS AM KRONBERGER HANG 3 SCHWALBACH/TAUNUS, DE-65824 GM 49-619-6806100 / 49-616-9806149 |
BEHRING NEPHELOMETER II | ANTISERUM TO HUMAN IGG |
| 8 | DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311 |
ANTISERUM TO HUMAN IGG | ANTISERUM TO HUMAN IGG |
| 9 | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820 |
IGG SPQ TEST SYSTEM KIT | TURBIDIMETRIC METHOD TO DETERMINE IGG |
| 10 | HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845 |
IGG, ANTIGEN, ANTISERUM, CONTROL | IGG, ANTIGEN, ANTISERUM, CONTROL |
| 11 | HELENA LABORATORIES 1530 LINDBERGH DR. BEAUMONT, TX 77704 US 409-842-3714 / 409-842-3714 271 |
MULTIPLE | IGG IMMUNOGLOBULIN ANTISERUM |
| 12 | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229 |
GULLSORB IGG INACTIVATION REAGENT | IGG INACTIVATION REAGENT |
| 13 | PANBIO, INC. 9075 GUILFORD RD. COLUMBIA, MD 21046 US 410-381-8550 231 / 410-381-8550 231 |
MINI RAPI-SEP-M | IGG REMOVAL DEVICE |
| 14 | PHADIA AB RAPSGATAN 7 UPPSALA, SE-754 50 SW 46-18-165000 / 46-18-163775 |
MULTIPLE | VARIOUS |
| 15 | RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413 |
RANDOX IGG (IMMUNOTURBIOIMETRIC) | IGG |
| 16 | RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413 |
RANDOX IGG (IMMUNOTURBIDIMETRIC) | IGG |
| 17 | RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413 |
RANDOX IGG (IMMUNOTURBIOIMETRIC) | IGG |
| 18 | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413 |
RANDOX IGG (IMMUNOTURBIDIMETRIC) | IGG |
| 19 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
ADVIA 1650 IMMUNOGLOBULIN G (IGG) ASSAY | IMMUNOGLOBULIN G (IGG) ASSAY |
| 20 | THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000 |
IGG SUBCLASS RID KIT | IGG SUBCLASS RID KIT |
| 21 | THE BINDING SITE, INC. 5889 OBERLIN DR., SUITE 101 SAN DIEGO, CA 92121 US 858-453-9177 / 858-453-9177 |
IMMUNOLOGICAL TEST SYSTEM | |
| 22 | ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901 |
ZORBA(R) IGG REMOVAL REAGENTS | IGG REMOVAL REAGENT |
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