| Primary Device ID | 10811877011191 |
| NIH Device Record Key | e836b536-faa7-4768-991a-067738b42c44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BinaxNOW RSV |
| Version Model Number | 430-122 |
| 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 | 10811877011191 [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 |
| 10811877011191 | A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash an |
| 10811877011184 | A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash an |
| 10811877011177 | A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash an |
| 10811877011160 | A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash an |