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 Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD| 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
| 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 [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 |
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