| Primary Device ID | 00842768012334 |
| NIH Device Record Key | 2bbb4fec-130d-480e-8e11-369c7fa9b4c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N Cuvette Segments for BN ProSpec® |
| Version Model Number | 10446539 |
| Catalog Number | OVLK31 |
| Company DUNS | 388240673 |
| Company Name | Siemens Healthcare Diagnostics Products GmbH |
| Device Count | 300 |
| 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 | 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 | 00842768012334 [Primary] |
| GS1 | 00842768024788 [Unit of Use] |
| JZW | NEPHELOMETER |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-31 |
| 00630414321837 - INNOVANCE Apixaban Controls | 2025-07-28 For quality control of the INNOVANCE ANTI-XA assay for the quantitativedetermination of apixaban in citrated human plasma. |
| 00630414321844 - INNOVANCE Apixaban Standard | 2025-07-28 For calibration of the INNOVANCE ANTI-XA assay for the quantitativedetermination of the concentration of apixaban in citrated hu |
| 00630414640204 - INNOVANCE Anti-Xa | 2025-07-28 In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma. |
| 00630414240336 - INNOVANCE Apixaban Controls | 2024-12-04 INNOVANCE Apixaban Controls |
| 00630414240343 - INNOVANCE Apixaban Standards | 2024-12-04 INNOVANCE Apixaban Standards |
| 00630414240404 - INNOVANCE Anti-Xa | 2024-12-04 In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma. |
| 00842768018800 - BC von Willebrand Reagent | 2024-09-20 Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination |
| 00842768019661 - LA 2 Confirmation Reagent | 2024-04-08 LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants |