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 ID00842768024870
NIH Device Record Key3c0fa666-2147-4759-8077-64372d25ab5a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFA-100® System
Version Model Number10444868
Catalog NumberB4170-00
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100842768024870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOZSYSTEM, AUTOMATED PLATELET AGGREGATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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00630414240404 - INNOVANCE Anti-Xa2024-12-04 In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma.
00842768018800 - BC von Willebrand Reagent2024-09-20 Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
00842768019661 - LA 2 Confirmation Reagent2024-04-08 LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants
00842768019654 - LA 1 Screening Reagent2024-04-08 LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
00842768019678 - LA Control Low2024-04-08 LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
00842768019685 - LA Control High2024-04-08 LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays

Trademark Results [PFA-100]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PFA-100
PFA-100
74440207 2091553 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
1993-09-27
PFA-100
PFA-100
74333239 not registered Dead/Abandoned
BAXTER DIAGNOSTICS INC.
1992-11-20

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