Dade® Thrombin Reagent B4233-27

GUDID 00842768003950

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies

Siemens Healthcare Diagnostics Products GmbH

Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting
Primary Device ID00842768003950
NIH Device Record Key5a0b2d4b-e331-4e59-a8c7-1f64ccd3f9d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDade® Thrombin Reagent
Version Model Number10445721
Catalog NumberB4233-27
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count10
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
GS100842768003950 [Primary]
GS100842768019500 [Unit of Use]

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

On-Brand Devices [Dade® Thrombin Reagent]

00842768003950Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples fo
00842768003943Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples fo

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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