FDA UDI
In Commercial Distribution
🇺🇸 United States
BinaxNOW Legionella Urinary Antigen Card
DI: 10811877011023
·
Model: 852-000
·
Alere Scarborough, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BinaxNOW Legionella Urinary Antigen Card
- Primary DI
- 10811877011023
- Version / Model
- 852-000
- Company Name
- Alere Scarborough, Inc.
- Labeler DUNS
- 154148498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-08
- Public Version
- 3
- Public Version Date
- 2023-09-12
- Public Version Status
- Update
- Public Device Record Key
- 04ea491b-2bce-4f2e-a4be-7ee2bce316bc
Device Description
The BinaxNOW Legionella Urinary Antigen Card is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in urine specimens from patients with symptoms of pneumonia.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| MJH | Legionella, Spp., Elisa | Microbiology | 866.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51054 | Legionella pneumophila antigen 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 antigens from one or multiple serogroups of Legionella pneumophila 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 Legionella pneumophila, the bacteria associated with Legionnaires' disease. 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 | 10811877011023 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070522 | 000 |