| Primary Device ID | 07613336156544 |
| NIH Device Record Key | 9224fe76-cdff-4741-a14e-c7dad2c74f80 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cobas Liat Strep A Script Version 1.27 |
| Version Model Number | 08403856001 |
| Catalog Number | 08403856001 |
| Company DUNS | 071674100 |
| Company Name | Roche Molecular Systems, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613336156544 [Primary] |
| PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-11-17 |
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