| Primary Device ID | 05056080501253 |
| NIH Device Record Key | 543f9a4f-dd93-4ad4-b5f6-db63e86fe283 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PathoDx Strep B Grouping Latex |
| Version Model Number | R62031 |
| 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 | 05056080501253 [Primary] |
| GTZ | Antisera, All Groups, Streptococcus Spp. |
| 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 |
| 05056080500775 - Salmonella H z Agglutinating Sera | 2021-07-29 |
| 05056080501031 - Vibrio cholerae Inaba Agglutinating Sera | 2021-07-29 |
| 05056080501239 - PathoDx Strep Grouping Kit | 2021-07-29 |
| 05056080501246 - PathoDx Strep A Grouping Latex | 2021-07-29 |
| 05056080501253 - PathoDx Strep B Grouping Latex | 2021-07-29 |
| 05056080501253 - PathoDx Strep B Grouping Latex | 2021-07-29 |
| 05056080501260 - PathoDx Strep C Grouping Latex | 2021-07-29 |
| 05056080501277 - PathoDx Strep F Grouping Latex | 2021-07-29 |
| 05056080501284 - PathoDx Strep G Grouping Latex | 2021-07-29 |