FDA.reportPublic FDA data

RAMP® Myoglobin TEST KIT; 25 TESTS

Primary DI
10627966005022
Brand
RAMP® Myoglobin TEST KIT; 25 TESTS
Company
Response Biomedical Corp
Model
C1103
Catalog number
C1103
Device description
The RAMP® Myoglobin test is a quantitative immunochromatographic test for the determination of Myoglobin 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
DDRMyoglobin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDRMyoglobin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012040000RAMP MYOGLOBIN ASSAYResponse Biomedical Corp.2001-12-18DDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627966005022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1062796600502210627966005022

GMDN Terms#

Term, Definition table
TermDefinition
Myoglobin 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 myoglobin 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
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
07613336147863Tina-quant Myoglobin Gen.2Roche Diagnostics GmbHDDR2020-08-21
00630414285047N Latex MyoglobinSiemens Healthcare Diagnostics Products GmbHDDR2020-05-29
00380740174910AlinityAbbott Ireland DiagnosticsDDR2019-10-09
00380740174903AlinityAbbott Ireland DiagnosticsDDR2019-07-08
00895160002496Fluoro-CheckTM AMI 3 in 1NANO-DITECH CORPORATIONDDR2019-05-24
30014613337157TriageQUIDEL CARDIOVASCULAR INC.DDR2018-11-01
30014613337164TriageQUIDEL CARDIOVASCULAR INC.DDR2018-11-01
30014613337911TriageQUIDEL CARDIOVASCULAR INC.DDR2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.DDR2018-11-01
00630414598468Atellica IM Calibrator USiemens Healthcare Diagnostics Inc.DDR2018-02-06
00630414599663Atellica IM MYOSiemens Healthcare Diagnostics Inc.DDR2018-02-06
00630414599670Atellica IM MYOSiemens Healthcare Diagnostics Inc.DDR2018-02-06
00630414599687Atellica IM MYO MCMSiemens Healthcare Diagnostics Inc.DDR2018-02-06
04015630940059Elecsys MyoglobinRoche Diagnostics GmbHDDR2017-04-21
04015630939541CalSet MyoglobinRoche Diagnostics GmbHDDR2017-04-17
00817089020610DiazymeDIAZYME LABORATORIES, INC.DDR2016-11-03
00817089020627DiazymeDIAZYME LABORATORIES, INC.DDR2016-11-03
00817089020634DiazymeDIAZYME LABORATORIES, INC.DDR2016-11-03
00895160002458Nano-CheckTM 4 in 1 TestNANO-DITECH CORPORATIONDDR2016-10-03
00899722002719Alere Triage®Alere San Diego, Inc.DDR2016-09-26
00899722002740Alere Triage®Alere San Diego, Inc.DDR2016-09-26
14560189210094ST AIA-PACK MyoglobinTOSOH CORPORATIONDDR2016-09-24
B176131Antiserum to Human MyoglobinKENT LABORATORIES INCDDR2016-09-24
04560189211018ST AIA-PACK Myoglobin CALIBRATOR SETTOSOH CORPORATIONDDR2016-09-24
04560189211025ST AIA-PACK Myoglobin SAMPLE DILUTING SOLUTIONTOSOH CORPORATIONDDR2016-09-24
05055273204681MYO CAL SETRANDOX LABORATORIES LIMITEDDDR2016-09-24
00842768004490Stratus® CS Acute Care™ CKMB TestPakSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00842768004506Stratus® CS Acute Care™ CKMB CalPakSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00842768004513Stratus® CS Acute Care™ CKMB DilPakSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00842768004520Stratus® CS Acute Care™ cTNI TestPakSiemens Healthcare Diagnostics Inc.DDR2016-09-24