Dade® Innovin® B4212-50
GUDID 00842768003806
For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent| Primary Device ID | 00842768003806 |
| NIH Device Record Key | 7f10725c-8848-4fcf-819f-47ea9e2361f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dade® Innovin® |
| Version Model Number | 10445706 |
| Catalog Number | B4212-50 |
| Company DUNS | 388240673 |
| Company Name | Siemens Healthcare Diagnostics Products GmbH |
| Device Count | 10 |
| 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 |
| 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 |
| 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 | 00842768003806 [Primary] |
| GS1 | 00842768019586 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K974343
FDA Product Code
| GJS | TEST, TIME, PROTHROMBIN |
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 |
On-Brand Devices [Dade® Innovin®]
| 00630414023496 | For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated hu |
| 00630414023489 | For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated hu |
| 00630414023472 | For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated hu |
| 00842768003806 | For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated hu |
| 00842768003790 | For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated hu |
| 00842768003783 | For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated hu |
Trademark Results [Dade]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DADE 97004218 not registered Live/Pending |
Hernandez, Abnel 2021-08-31 |
 DADE 86034975 4616131 Live/Registered |
GUANGDONG JIYU PORCELAIN CORP., LTD. 2013-08-12 |
 DADE 75036129 2245269 Live/Registered |
Siemens Healthcare Diagnostics Inc. 1995-12-22 |
 DADE 74100946 1687376 Dead/Cancelled |
Aldi Inc. 1990-09-27 |
 DADE 73192744 1143179 Dead/Cancelled |
American Hospital Supply Corporation 1978-11-09 |
 DADE 73182644 1138626 Dead/Cancelled |
T.K. PRODUCTIONS, INC. 1978-08-18 |
 DADE 72336910 0913150 Dead/Expired |
AMERICAN HOSPITAL SUPPLY CORPORATION 1969-09-03 |
 DADE 72328146 0892303 Live/Registered |
AMERICAN HOSPITAL SUPPLY CORPORATION 1969-05-23 |
 DADE 71687854 0643431 Dead/Expired |
DADE REAGENTS, INC. 1955-05-19 |
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