Dade® PFA Trigger Solution B4170-50

GUDID 00842768003691

To aid in the detection of platelet dysfunction in citrated human whole blood

Siemens Healthcare Diagnostics Products GmbH

Platelet aggregation study IVD, reagent
Primary Device ID00842768003691
NIH Device Record Keybe8e5fc1-34d5-40de-b210-5be8fd9db5f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDade® PFA Trigger Solution
Version Model Number10445701
Catalog NumberB4170-50
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count3
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842768003691 [Primary]
GS100842768019791 [Unit of Use]

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

Devices Manufactured by Siemens Healthcare Diagnostics Products GmbH

00630414240336 - INNOVANCE Apixaban Controls2024-12-04 INNOVANCE Apixaban Controls
00630414240343 - INNOVANCE Apixaban Standards2024-12-04 INNOVANCE Apixaban Standards
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 [Dade]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DADE
DADE
97004218 not registered Live/Pending
Hernandez, Abnel
2021-08-31
DADE
DADE
86034975 4616131 Live/Registered
GUANGDONG JIYU PORCELAIN CORP., LTD.
2013-08-12
DADE
DADE
75036129 2245269 Live/Registered
Siemens Healthcare Diagnostics Inc.
1995-12-22
DADE
DADE
74100946 1687376 Dead/Cancelled
Aldi Inc.
1990-09-27
DADE
DADE
73192744 1143179 Dead/Cancelled
American Hospital Supply Corporation
1978-11-09
DADE
DADE
73182644 1138626 Dead/Cancelled
T.K. PRODUCTIONS, INC.
1978-08-18
DADE
DADE
72336910 0913150 Dead/Expired
AMERICAN HOSPITAL SUPPLY CORPORATION
1969-09-03
DADE
DADE
72328146 0892303 Live/Registered
AMERICAN HOSPITAL SUPPLY CORPORATION
1969-05-23
DADE
DADE
71687854 0643431 Dead/Expired
DADE REAGENTS, INC.
1955-05-19

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