FDA.reportPublic FDA data

RAMP® Troponin I TEST KIT; 25 TESTS

Primary DI
10627966005008
Brand
RAMP® Troponin I TEST KIT; 25 TESTS
Company
Response Biomedical Corp
Model
C1101
Catalog number
C1101
Device description
The RAMP® Troponin I test is a quantitative immunochromatographic test for the determination of TnI in EDTA whole blood
Published
2016-09-05
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
MMIImmunoassay Method, Troponin Subunit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033745000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033745000RAMP TROPONIN I ASSAYResponse Biomedical Corp.2004-05-17MMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627966005008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1062796600500810627966005008

GMDN Terms#

Term, Definition table
TermDefinition
Troponin I 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 troponin I 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
10627966005015RAMP® CK-MB TEST KIT; 25 TESTSC1102C11022016-09-05
10627966005022RAMP® Myoglobin TEST KIT; 25 TESTSC1103C11032016-09-05
10627966005046RAMP® NT-proBNP TEST KIT; 25 TESTSC1105C11052016-09-15
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
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00054749003051i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
04987595301803PATHFAST hs-cTnI-IIPHC CORPORATIONMMI2024-05-01
00380740194062AlinityABBOTT IRELANDMMI2022-07-08
00380740194079AlinityABBOTT IRELANDMMI2022-07-08
07613336158951Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2022-03-01
07613336158982Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2021-09-23
00894175000466RapiCard™ InstaTestDiagnostic Automation, Inc.MMI2021-08-27
00083059070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KITBIOMERICA, INC.MMI2020-07-01
00630414293783Atellica IM TNIHSiemens Healthcare Diagnostics Inc.MMI2020-05-31
00630414293790Atellica IM TnI-UltraSiemens Healthcare Diagnostics Inc.MMI2020-05-31
00380740175498ARCHITECTABBOTT IRELANDMMI2019-12-03
00380740175504ARCHITECTABBOTT IRELANDMMI2019-12-03
00842768037726Dimension EXL LOCI Troponin I High SensitiveSiemens Healthcare Diagnostics Inc.MMI2019-10-16
00842768037719Dimension Vista Troponin I High SensitiveSiemens Healthcare Diagnostics Inc.MMI2019-08-05
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