Dade® CA System Buffer B4265-37

GUDID 00842768039416

For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems

Siemens Healthcare Diagnostics Products GmbH

Multiple coagulation factor IVD, reagent
Primary Device ID00842768039416
NIH Device Record Keyc1c5d8ef-203d-4bf7-976d-968c95cafc1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDade® CA System Buffer
Version Model Number10873440
Catalog NumberB4265-37
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count8
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
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 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842768019845 [Unit of Use]
GS100842768039416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQJSYSTEM, FIBRINOGEN DETERMINATION

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

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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
00630414640433 - vWF Ag2024-04-08 For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma
00630414639352 - Berichrom Plasminogen2024-04-02 Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders
00630414639437 - Berichrom a2-Antiplasmin2024-04-02 Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in mana

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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