| Primary Device ID | 00630414002903 |
| NIH Device Record Key | 163a51c9-4cfe-4570-a99e-6e766d67f46b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BN II System |
| Version Model Number | 11254820 |
| Catalog Number | OVIA112 |
| Company DUNS | 388240673 |
| Company Name | Siemens Healthcare Diagnostics Products GmbH |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| XX@XX.XX | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)664-3822 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414002903 [Primary] |
| DEW | IGG, ANTIGEN, ANTISERUM, CONTROL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
| 00842768019661 - LA 2 Confirmation Reagent | 2024-04-08 LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants |
| 00842768019654 - LA 1 Screening Reagent | 2024-04-08 LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants |
| 00842768019678 - LA Control Low | 2024-04-08 LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays |
| 00842768019685 - LA Control High | 2024-04-08 LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays |
| 00630414640433 - vWF Ag | 2024-04-08 For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma |
| 00630414639352 - Berichrom Plasminogen | 2024-04-02 Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders |
| 00630414639437 - Berichrom a2-Antiplasmin | 2024-04-02 Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in mana |
| 00630414639444 - Berichrom Antithrombin III (A) | 2024-04-02 Determination of the functional activity of antithrombin III (AT III) in human plasma |