FDA.reportPublic FDA data

RAMP® Flu A + B TEST KIT; 25 TESTS

Primary DI
10627966005176
Brand
RAMP® Flu A + B TEST KIT; 25 TESTS
Company
Response Biomedical Corp
Model
C1107
Catalog number
C1107
Device description
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.
Published
2017-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627966005176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1062796600517610627966005176

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B virus antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen, using a fluorescent immunoassay method.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store unopened at 15 to 30°C (59 to 86°F). Do not freeze.

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
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
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