FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Response
DI: 00722066001974
·
Model: RSV-19C30
·
BTNX Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- Rapid Response
- Primary DI
- 00722066001974
- Version / Model
- RSV-19C30
- Catalog Number
- RSV-19C30
- Company Name
- BTNX Inc
- Labeler DUNS
- 251005005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2016-10-25
- Public Version
- 4
- Public Version Date
- 2023-04-20
- Public Version Status
- Update
- Public Device Record Key
- 4e1bbce8-47a6-4d4b-a8b4-fc44b7cdcd3b
Device Description
Rapid Response Respiratory Syncytial Virus Test Cassette - 30 tests/ kit are for the qualitative detection of Respiratory Syncytial Virus Antigen in Nasopharyngeal specimens.
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Microbiology | 866.3480 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48262 | Influenza virus/respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapid | A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of antigens from influenza viruses (e.g., influenza A, influenza B) and respiratory syncytial virus (RSV) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00722066001974 | GS1 | ||||
| Unit of Use | 00722066004265 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022845 | 000 |