FDA UDI
In Commercial Distribution
🇺🇸 United States
BinaxNOW™ Legionella Control Swab Pack
DI: 10811877011054
·
Model: 852-010
·
Alere Scarborough, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BinaxNOW™ Legionella Control Swab Pack
- Primary DI
- 10811877011054
- Version / Model
- 852-010
- Company Name
- Alere Scarborough, Inc.
- Labeler DUNS
- 154148498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-15
- Public Version
- 2
- Public Version Date
- 2023-09-12
- Public Version Status
- Update
- Public Device Record Key
- 27aeae37-cd5b-44d7-884b-9bc5f8ea8d1e
Device Description
Control Swabs to be used with the BinaxNOW™ Legionella Urinary Antigen Card.
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 |
|---|---|---|---|---|
| 51058 | Legionella pneumophila antigen IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple serogroups of Legionella pneumophila bacteria in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10811877011054 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070522 | 000 |