Enzygnost® F1+2 monoclonal OPBD03
GUDID 00842768006760
Quantitative determination of prothrombin fragment F 1+2 in human plasma
Siemens Healthcare Diagnostics Products GmbH
Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA) Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00842768006760 |
| NIH Device Record Key | b6f50b9f-67f6-4291-b2e7-b8c10a2f3c7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enzygnost® F1+2 monoclonal |
| Version Model Number | 10445978 |
| Catalog Number | OPBD03 |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842768006760 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042687
FDA Product Code
| MIF | PROTHROMBIN FRAGMENT 1.2 |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by Siemens Healthcare Diagnostics Products GmbH
| 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 |
Trademark Results [Enzygnost]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENZYGNOST 78395401 3075642 Dead/Cancelled |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTSGMBH 2004-04-02 |
 ENZYGNOST 73271049 1184343 Dead/Cancelled |
Behringwerke Aktiengesellschaft 1980-07-21 |
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