FDA.reportPublic FDA data

RAMP® Flu A + B Control Swabs

Primary DI
10627966005190
Brand
RAMP® Flu A + B Control Swabs
Company
Response Biomedical Corp
Model
C1135
Catalog number
C1135
Device description
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
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
10627966005190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1062796600519010627966005190

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B virus antigen IVD, controlA material which is used to verify the performance of an assay 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.

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 30 degree celsius. Do not freeze. Contents are stable until the expiration date printed on the box.

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
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