FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RAMP® Flu A + B TEST KIT; 25 TESTS
DI: 10627966005176
·
Model: C1107
·
Response Biomedical Corp
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RAMP® Flu A + B TEST KIT; 25 TESTS
- Primary DI
- 10627966005176
- Version / Model
- C1107
- Catalog Number
- C1107
- Company Name
- Response Biomedical Corp
- Labeler DUNS
- 248609018
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-31
- Public Version
- 5
- Public Version Date
- 2025-11-14
- Public Version Status
- Update
- Public Device Record Key
- 98c85364-2db3-4783-905d-a518c82bbf32
- Distribution End Date
- 2018-01-11
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10627966005176 | GS1 |
Customer Contacts
- Phone
- +1.888.525.7267
- [email protected]
Device Sizes
| Type | Value | Unit | 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 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store unopened at 15 to 30°C (59 to 86°F). Do not freeze.