| Primary Device ID | 10811877011207 |
| NIH Device Record Key | 3c2db117-6bd2-49e1-829f-404977dab227 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BinaxNOW RSV Control Swab Kit |
| Version Model Number | 430-080 |
| Company DUNS | 154148498 |
| Company Name | Alere Scarborough, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10811877011207 [Primary] |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-24 |
| Device Publish Date | 2020-09-16 |
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| 10811877010798 - DIGIVAL Calibration Check Card Pack | 2023-09-14 A calibration check card verifies that the DIGIVAL is functioning correctly |
| 00811877011477 - BinaxNOW COVID-19 Antigen Self Test | 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. |
| 00811877011507 - BinaxNOW COVID-19 Antigen Self Test | 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. |
| 00811877011798 - BinaxNOW COVID-19 Antigen Self Test | 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. |
| 10811877010019 - Alere i Influenza A & B 2 | 2023-09-12 A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimen |