PFA-100® System B4170-00
GUDID 00842768024870
To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
Platelet aggregation analyser IVD, semi-automated| Primary Device ID | 00842768024870 |
| NIH Device Record Key | 3c0fa666-2147-4759-8077-64372d25ab5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PFA-100® System |
| Version Model Number | 10444868 |
| Catalog Number | B4170-00 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842768024870 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060489
FDA Product Code
| JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION |
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
| 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 |
Trademark Results [PFA-100]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PFA-100 74440207 2091553 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1993-09-27 |
 PFA-100 74333239 not registered Dead/Abandoned |
BAXTER DIAGNOSTICS INC. 1992-11-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.