responsebio.comMODIFICATION TO: RAMP INFLUENZA A/B ASSAY
Response Biomedical Corp.
Response Biomedical Corp.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004205692 | 3004205692 | Response Biomedical Corp. | 1 | N | 2026-01-01 | 1781-75th Avenue W. Vancouver British Columbia CA V6P 6P2 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10627966005008 | RAMP® Troponin I TEST KIT; 25 TESTS - The RAMP® Troponin I test is a quantitative immunochromatographic test for the determination of TnI in EDTA whole blood | +1.888.525.7267 | customersupport@responsebio.com |
| 10627966005015 | RAMP® CK-MB TEST KIT; 25 TESTS - The RAMP® CK-MB test is a quantitative immunochromatographic test for the determination of CK-MB in EDTA whole blood. | +1.888.525.7267 | customersupport@responsebio.com |
| 10627966005176 | RAMP® Flu A + B TEST KIT; 25 TESTS - The RAMP® Flu A + B test is a qualitative immunochromatographic test that utilizes the RAMP® 200 instrument for the differential determination of Influenza A and Influenza B in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples. | +1.888.525.7267 | customersupport@responsebio.com |
| 10627966005183 | RAMP® RSV TEST KIT; 25 TESTS - The RAMP® RSV test is a qualitative immunochromatographic test that utilizes the RAMP® 200 instrument for the detection of RSV F-protein antigens in nasal wash, nasopharyngeal aspirate (NP aspirate), and nasopharyngeal swab (NP swab) samples | +1.888.525.7267 | customersupport@responsebio.com |
| 10627966005190 | RAMP® Flu A + B Control Swabs - The RAMP® Flu A + B control swabs are additional external control reagents to be used with the RAMP® Flu A + B test as part of a routine quality control program | +1.888.525.7267 | customersupport@responsebio.com |
| 10627966005206 | RAMP® RSV Control Swabs - The RAMP® RSV control swabs are additional external control reagents to be used with RAMP® RSV test kits as part of a routine quality control program | +1.888.525.7267 | customersupport@responsebio.com |
| 10627966005237 | RAMP® 200 CM Control Module - RAMP® 200 Control Module manages the sample test results that it receives from the Test Module. | +1.888.525.7267 | customersupport@responsebio.com |
| 10627966005244 | RAMP® 200 TM Test Module - RAMP® 200 Test Module analyzes sample tests | +1.888.525.7267 | customersupport@responsebio.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 20065 | 1628442323 | K110534 | RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 | JJY | 2012-01-23 |
| 20065 | 1395408227 | K091235 | RAMP RSV ASSAY | GQG | 2009-07-24 |
| 20065 | 1633444475 | K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | JJY | 2008-06-02 |
| 20065 | 1769616701 | K063662 | RAMP NT-PROBNP ASSAY | NBC | 2008-07-21 |
| 20065 | 1393999867 | K033747 | RAMP CK-MB ASSAY | JHX | 2004-05-17 |
| 20065 | 1355858082 | K033745 | RAMP TROPONIN I ASSAY | MMI | 2004-05-17 |
| 20065 | 1405294668 | K012040 | RAMP MYOGLOBIN ASSAY | DDR | 2001-12-18 |
| 20065 | 1019567628 |
Product Codes Associated With Registrations#
PMN#
RAMP RSV ASSAY
RESPONSE BIOMEDICAL CORP.
RAMP NT-PROBNP ASSAY
RESPONSE BIOMEDICAL CORP.
RAMP INFLUENZA A/B ASSAY
RESPONSE BIOMEDICAL CORP.
RAMP CK-MB ASSAY
RESPONSE BIOMEDICAL CORP.
RAMP TROPONIN I ASSAY
RESPONSE BIOMEDICAL CORP.
RAMP MYOGLOBIN ASSAY
RESPONSE BIOMEDICAL CORP.
GUDID#
RAMP® Flu A + B TEST KIT; 25 TESTS - The RAMP® Flu A + B test is a qualitative immunochromatographic test that utilizes the RAMP® 200 instrument for the differential determination of Influenza A and Influenza B in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples.
2017-08-31
RAMP® RSV TEST KIT; 25 TESTS - The RAMP® RSV test is a qualitative immunochromatographic test that utilizes the RAMP® 200 instrument for the detection of RSV F-protein antigens in nasal wash, nasopharyngeal aspirate (NP aspirate), and nasopharyngeal swab (NP swab) samples
2017-08-31
RAMP® Flu A + B Control Swabs - The RAMP® Flu A + B control swabs are additional external control reagents to be used with the RAMP® Flu A + B test as part of a routine quality control program
2017-08-31
RAMP® RSV Control Swabs - The RAMP® RSV control swabs are additional external control reagents to be used with RAMP® RSV test kits as part of a routine quality control program
2017-08-31
RAMP® 200 CM Control Module - RAMP® 200 Control Module manages the sample test results that it receives from the Test Module.
2017-08-31
RAMP® 200 TM Test Module - RAMP® 200 Test Module analyzes sample tests
2017-08-31
RAMP® Troponin I TEST KIT; 25 TESTS - The RAMP® Troponin I test is a quantitative immunochromatographic test for the determination of TnI in EDTA whole blood
2016-09-05
RAMP® CK-MB TEST KIT; 25 TESTS - The RAMP® CK-MB test is a quantitative immunochromatographic test for the determination of CK-MB in EDTA whole blood.
2016-09-05
RAMP® Myoglobin TEST KIT; 25 TESTS - The RAMP® Myoglobin test is a quantitative immunochromatographic test for the determination of Myoglobin in EDTA whole blood.
2016-09-05
RAMP® NT-proBNP TEST KIT; 25 TESTS - The RAMP® NT-proBNP test is a quantitative immunochromatographic test for the determination of NT-proBNP in EDTA whole blood.
2016-09-15
RAMP® CARDIAC CONTROLS; LEVEL 1 - The RAMP® Cardiac Controls are prepared from human plasma, human serum and human proteins. Preservatives and stabilizers have been added to maintain product integrity. The RAMP® Cardiac Controls are ready-to-use liquid control requiring no reconstitution or frozen storage.
2017-08-31
RAMP® CARDIAC CONTROLS; LEVEL 2 - The RAMP® Cardiac Controls are prepared from human plasma, human serum and human proteins. Preservatives and stabilizers have been added to maintain product integrity. The RAMP® Cardiac Controls are ready-to-use liquid control requiring no reconstitution or frozen storage.
2017-08-31
RAMP® CARDIAC CONTROLS; LEVEL 3 - The RAMP® Cardiac Controls are prepared from human plasma, human serum and human proteins. Preservatives and stabilizers have been added to maintain product integrity. The RAMP® Cardiac Controls are ready-to-use liquid control requiring no reconstitution or frozen storage.
2017-08-31
RAMP® 1 Clinical Reader System - The RAMP® System is a rapid, quantitative immunochromatographic system for performing in vitro diagnostic analyses on a variety of analytes. The System can be used for various applications, from use in a clinical setting (point-of-care, central or STAT laboratory) to use for onsite screening of environmental samples.
2017-08-31
RAMP® Cardiac Controls - Level 1 - The RAMP® Cardiac Controls are prepared from human plasma, human serum and human proteins. Preservatives and stabilizers have been added to maintain product integrity. The RAMP® Cardiac Controls are ready-to-use liquid control requiring no reconstitution or frozen storage
2019-12-20
RAMP® Cardiac Controls - Level 2 - The RAMP® Cardiac Controls are prepared from human plasma, human serum and human proteins. Preservatives and stabilizers have been added to maintain product integrity. The RAMP® Cardiac Controls are ready-to-use liquid control requiring no reconstitution or frozen storage.
2019-12-20