| Primary Device ID | 05056080501789 |
| NIH Device Record Key | ce4326e1-d633-4b9e-8efe-fe113a3022e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PathoDX RSV Direct Specimen |
| Version Model Number | R62370 |
| Company DUNS | 232600853 |
| Company Name | REMEL EUROPE LIMITED |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Phone | +4401256694238 |
| microbiology.techsupport.uk@thermofisher.com | |
| Phone | +4401256694238 |
| microbiology.techsupport.uk@thermofisher.com | |
| Phone | +4401256694238 |
| microbiology.techsupport.uk@thermofisher.com | |
| Phone | +4401256694238 |
| microbiology.techsupport.uk@thermofisher.com | |
| Phone | +4401256694238 |
| microbiology.techsupport.uk@thermofisher.com | |
| Phone | +4401256694238 |
| microbiology.techsupport.uk@thermofisher.com | |
| Phone | +4401256694238 |
| microbiology.techsupport.uk@thermofisher.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05056080501789 [Primary] |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-29 |
| Device Publish Date | 2021-07-21 |