FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Response
DI: 00722066000311
·
Model: MON-13C15
·
BTNX Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
15
Basic Information
- Brand Name
- Rapid Response
- Primary DI
- 00722066000311
- Version / Model
- MON-13C15
- Catalog Number
- MON-13C15
- Company Name
- BTNX Inc
- Labeler DUNS
- 251005005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2016-10-25
- Public Version
- 6
- Public Version Date
- 2023-04-20
- Public Version Status
- Update
- Public Device Record Key
- d7903044-3178-4f83-9bcb-ffd37c8ae105
Device Description
Rapid Response Mononucleosis Test Cassettes - 15 tests/ kit are for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma.
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 |
|---|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | Immunology | 866.5640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49689 | Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00722066000311 | GS1 | ||||
| Unit of Use | 00722066004272 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042272 | 000 |