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VERSANT HCV RNA 3.0 ASSAY (BDNA)
 Request for Information Form |
 Contact Information
|
| Company Name |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
|
| Address |
333 CONEY ST.
|
| City, State, Zip |
WALPOLE, MA 02032 |
| Country |
US |
| FDA Owner/Operator Phone |
914-524-2955 |
| FDA Medical Specialty Code |
MI - Microbiology
|
| FDA Product Code |
MZP |
| FDA Classification Name |
ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS |
| FDA Device Classification Code |
Premarket Approval
|
| FDA Regulation Number |
NULL
|
| FDA Common Generic Name |
HCV VIRAL LOAD ASSAY |
| FDA Proprietary Device Name |
VERSANT HCV RNA 3.0 ASSAY (BDNA) |
| FDA Owner / Operator Number |
9096044 |
| FDA Owner / Operator Name |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
| FDA Establishment Registration Number |
1219913 |
| FDA Registered Establishment Name |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
| FDA Operation Code(s) |
MM - Manufacturer
MR - Remanufacturer
MS - Specification Developer
RR - Repackager/Relabeller
|
| FDA Listing Date |
02-20-04 |
| FDA Listing Status Code |
Active
|
| Differentiation |
N/A |
| Keywords |
N/A |
| Description |
N/A |
| Brochure |
N/A |
| Product Website
|
N/A |
Competitors of SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
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
100 AND 200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064 US
847-937-6100 / 847-938-3471
|
LCX HCV RNA QUANTITATIVE ASSAY |
NUCLEIC ACID TEST TO DETECT HCV |
| 2 |
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018 US
847-937-6100 / 847-938-3471
|
ABBOTT REAL TIME HCV |
PCR HCV ASSAY |
| 3 |
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121 US
858-410-8000 / 858-410-8891
|
VERSANT TM HCV RNA QUALITATIVE ASSAY |
IN VITRO DIAGNOSTIC ASSAY FOR DETECTION OF HCV |
| 4 |
GEN-PROBE, INC.
10808 WILLOW CT.
SAN DIEGO, CA 92127 US
858-410-8000 / 858-410-8891
|
VERSANT(TM) HCV RNA QUALITATIVE ASSAY |
HEPATITIS C VIRUS RNA QUALITATIVE ASSAY |
| 5 |
NATIONAL GENETICS INSTITUTE
2112 COTNER AVE.
LOS ANGELES, CA 90025 US
310-996-6610 / 310-447-7881 113
|
ULTRAQUAL HCV RT - PCR ASSAY |
QUALITATIVE HEPATITIS C VIRUS REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION |
| 6 |
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
PLEASANTON, CA 94588 US
925-730-8110 / 925-730-8110
|
AMPLICOR(R) HCV TEST, V2.0, COBAS AMPLICOR(TM) HCV TEST, V2.0 |
VARIOUS HEPATITIS C VIRUS TESTS |
| 7 |
ROCHE MOLECULAR SYSTEMS, INC.
1145 ATLANTIC AVENUE
ALAMEDA, CA 94501 US
925-730-8110 / 925-730-8110
|
AMPLICOR(R) HCV TEST, V2.0, COBAS AMPLICOR(TM) HCV TEST, V2.0 |
VARIOUS HEPATITIS C VIRUS TESTS |
| 8 |
ROCHE MOLECULAR SYSTEMS, INC.
11 FRANKLIN AVE.
BELLEVILLE, NJ 07109 US
925-730-8110 / 925-730-8110
|
AMPLICOR(R) HCV TEST, V2.0, COBAS AMPLICOR(TM) HCV TEST, V2.0 |
VARIOUS HEPATITIS C VIRUS TESTS |
| 9 |
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HWY. 202
BRANCHBURG TOWNSHIP
SOMERVILLE, NJ 08876 US
925-730-8110 / 925-730-8110
|
AMPLICOR(R) HCV TEST, V2.0, COBAS AMPLICOR(TM) HCV TEST, V2.0 |
VARIOUS HEPATITIS C VIRUS TESTS |
| 10 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
725 POTTER ST.
BERKELEY, CA 94710 US
914-524-2955 / 510-705-5817
|
VERSANT HCV RNA 3.0 ASSAY (BDNA) |
HCV VIRAL LOAD ASSAY |
|
