AccessGUDID - DEVICE: RAMP® Flu A + B TEST KIT; 25 TESTS (10627966005176)

GUDID

Device Identifier (DI) Information

Brand Name: RAMP® Flu A + B TEST KIT; 25 TESTS
Version or Model: C1107
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C1107
Company Name: Response Biomedical Corp

Primary DI Number: 10627966005176
Issuing Agency: GS1
Commercial Distribution End Date: January 11, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 248609018 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
49117	Influenza A/B virus antigen IVD, kit, fluorescent immunoassay	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store unopened at 15 to 30°C (59 to 86°F). Do not freeze.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: One test kit with 25 pouches, each containing 1 RAMP® test cartridge and 1 test tip, and 25 RAMP® buffer vials

Device Record Status

Public Device Record Key: 98c85364-2db3-4783-905d-a518c82bbf32
Public Version Date: November 14, 2025
Public Version Number: 5
DI Record Publish Date: August 31, 2017