Response Biomedical Corp.

FDA Registration(s)#

Registration, FEI, Name table
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#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
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

responsebio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
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#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JJY	2	2012-01-23
GQG	1	2009-07-24
NBC	1	2008-07-21
JHX	1	2004-05-17
MMI	1	2004-05-17
DDR	1	2001-12-18

PMN#

MODIFICATION TO: RAMP INFLUENZA A/B ASSAY

2009-10-21

Response Biomedical Corp.

RAMP RSV ASSAY

2009-07-24

RESPONSE BIOMEDICAL CORP.

RAMP NT-PROBNP ASSAY

2008-07-21

RESPONSE BIOMEDICAL CORP.

RAMP INFLUENZA A/B ASSAY

2008-04-16

RESPONSE BIOMEDICAL CORP.

RAMP CK-MB ASSAY

2004-05-17

RESPONSE BIOMEDICAL CORP.

RAMP TROPONIN I ASSAY

2004-05-17

RESPONSE BIOMEDICAL CORP.

RAMP MYOGLOBIN ASSAY

2001-12-18

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.

Response Biomedical Corp

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

Response Biomedical Corp

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

Response Biomedical Corp

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

Response Biomedical Corp

2017-08-31

RAMP® 200 CM Control Module - RAMP® 200 Control Module manages the sample test results that it receives from the Test Module.

Response Biomedical Corp

2017-08-31

RAMP® 200 TM Test Module - RAMP® 200 Test Module analyzes sample tests

Response Biomedical Corp

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

Response Biomedical Corp

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.

Response Biomedical Corp

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.

Response Biomedical Corp

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.

Response Biomedical Corp

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.

Response Biomedical Corp

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.

Response Biomedical Corp

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.

Response Biomedical Corp

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.

Response Biomedical Corp

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

Response Biomedical Corp

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.

Response Biomedical Corp

2019-12-20