FDA.reportPublic FDA data

RAMP® NT-proBNP TEST KIT; 25 TESTS

Primary DI
10627966005046
Brand
RAMP® NT-proBNP TEST KIT; 25 TESTS
Company
Response Biomedical Corp
Model
C1105
Catalog number
C1105
Device description
The RAMP® NT-proBNP test is a quantitative immunochromatographic test for the determination of NT-proBNP in EDTA whole blood.
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBCTest, Natriuretic Peptide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBCTest, Natriuretic PeptideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063662000RAMP NT-PROBNP ASSAYResponse Biomedical Corp.2008-07-21NBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627966005046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1062796600504610627966005046

GMDN Terms#

Term, Definition table
TermDefinition
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at 2 to 8°C (35 to 46°F). Do not freeze

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.888.525.7267customersupport@responsebio.com

Regulatory Flags#

DUNS number
248609018
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10627966005176RAMP® Flu A + B TEST KIT; 25 TESTSC1107C11072017-08-31
10627966005183RAMP® RSV TEST KIT; 25 TESTSC1108C11082017-08-31
10627966005190RAMP® Flu A + B Control SwabsC1135C11352017-08-31
10627966005206RAMP® RSV Control SwabsC1136C11362017-08-31
10627966005237RAMP® 200 CM Control ModuleC2100C21002017-08-31
10627966005244RAMP® 200 TM Test ModuleC3100C31002017-08-31
10627966005008RAMP® Troponin I TEST KIT; 25 TESTSC1101C11012016-09-05
10627966005015RAMP® CK-MB TEST KIT; 25 TESTSC1102C11022016-09-05
10627966005022RAMP® Myoglobin TEST KIT; 25 TESTSC1103C11032016-09-05
10627966005077RAMP® CARDIAC CONTROLS; LEVEL 1 C2003-1C2003-12017-08-31
10627966005084RAMP® CARDIAC CONTROLS; LEVEL 2C2003-2C2003-22017-08-31
10627966005091RAMP® CARDIAC CONTROLS; LEVEL 3C2003-3C2003-32017-08-31
10627966005220RAMP® 1 Clinical Reader SystemC1100C11002017-08-31
10627966005299RAMP® Cardiac Controls - Level 1C5003-1C5003-12019-12-20
10627966005305RAMP® Cardiac Controls - Level 2C5003-2C5003-22019-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590786533Access BNP IIBeckman Coulter, Inc.NBC2026-03-30
05055845400596Alere NT-proBNP for Alinity Reagent Kit (200 Tests)AXIS-SHIELD DIAGNOSTICS LIMITEDNBC2025-02-26
15099590760823Access NT-proBNPBeckman Coulter, Inc.NBC2024-04-19
07613336217689Elecsys ProBNP IIRoche Diagnostics GmbHNBC2024-02-19
00630414284927ADVIA Centaur PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284934ADVIA Centaur PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284941Atellica IM PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284958Atellica IM PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
07613336191521Elecsys proBNP II ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
07613336191569Elecsys proBNP II ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
07613336191576Elecsys proBNP II STAT ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
10758750033300VITROSORTHO CLINICAL DIAGNOSTICSNBC2021-11-08
15099590750947Access BNP Beckman Coulter, Inc.NBC2021-08-18
14560189212876ST AIA-PACK BNPTOSOH CORPORATIONNBC2021-01-01
04560189212879ST AIA-PACK BNPTOSOH CORPORATIONNBC2021-01-01
00630414293462Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2020-05-31
00630414294032Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2020-05-31
00380740145279ARCHITECTAbbott GmbHNBC2019-01-21
00380740145286ARCHITECTAbbott GmbHNBC2019-01-21
30014613337706TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337966TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337973TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337980TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337997TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613338031TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
00630414597980Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2017-12-22
00630414597997Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2017-12-22
00630414598024Atellica IM BNP QCSiemens Healthcare Diagnostics Inc.NBC2017-12-22
04015630939756Elecsys proBNP IIRoche Diagnostics GmbHNBC2017-04-21