FDA UDI
In Commercial Distribution
🇺🇸 United States
BinaxNOW Streptococcus pneumoniae Antigen Card
DI: 10811877011061
·
Model: 710-000
·
Alere Scarborough, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BinaxNOW Streptococcus pneumoniae Antigen Card
- Primary DI
- 10811877011061
- Version / Model
- 710-000
- Company Name
- Alere Scarborough, Inc.
- Labeler DUNS
- 154148498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-16
- Public Version
- 3
- Public Version Date
- 2023-09-12
- Public Version Status
- Update
- Public Device Record Key
- 7c1e7b32-03a6-4d56-b3d4-6288b23dff48
Device Description
The BinaxNOW Streptococcus pneumoniae Antigen Card is an in vitro rapid immunochromatographic assay for the detection of Streptococcus pneumoniae antigen in the urine of patients with pneumonia and in the cerebral spinal fluid of patients with meningitis.
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 |
|---|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | Microbiology | 866.3740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51770 | Streptococcus pneumoniae 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 Streptococcus pneumoniae bacteria 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. 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 | 10811877011061 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012521 | 000 |