FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Alere™ i Influenza A & B
DI: 10811877010804
·
Model: 425-024
·
Alere Scarborough, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alere™ i Influenza A & B
- Primary DI
- 10811877010804
- Version / Model
- 425-024
- Company Name
- Alere Scarborough, Inc.
- Labeler DUNS
- 154148498
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-03
- Public Version
- 3
- Public Version Date
- 2023-09-12
- Public Version Status
- Update
- Public Device Record Key
- b331a89b-0b33-4379-842e-39f72d140095
- Distribution End Date
- 2019-06-20
Device Description
A rapid, automated, molecular test for the qualitative detection of inuenza A and B viral nucleic acid in respiratory 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | Microbiology | 866.3980 | 2 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | Microbiology | 866.3980 | 2 |
| OOI | Real Time Nucleic Acid Amplification System | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47277 | Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from influenza A virus and/or influenza B virus in a clinical specimen, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10811877010804 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141520 | 000 |