| Primary Device ID | 08718734962625 |
| NIH Device Record Key | 5545c864-048f-49b5-b9a5-70462e2aa600 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CueSee VeriSTAT® |
| Version Model Number | S3 |
| Catalog Number | AN01902A03 |
| Company DUNS | 412925992 |
| Company Name | Eurotrol B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08718734962540 [Primary] |
| GS1 | 08718734962625 [Package] Contains: 08718734962540 Package: Box [5 Units] In Commercial Distribution |
| OHQ | Multi-Analyte Controls Unassayed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-06 |
| Device Publish Date | 2024-10-29 |
| 08718734962632 | CueSee VeriSTAT® LV is an unassayed quality control material for professional use to verify the |
| 08718734962625 | CueSee VeriSTAT® S3 is an unassayed quality control material for professional use to verify the |
| 08718734962618 | CueSee VeriSTAT® S2 is an unassayed quality control material for professional use to verify the |
| 08718734962526 | CueSee VeriSTAT® S1 is an unassayed quality control material for professional use to verify the |