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510(k) Data Aggregation
K Number
K050817Device Name
T-TEK
Manufacturer
R2 DIAGNOSTICS, INC.
Date Cleared
2005-12-12
(256 days)
Product Code
GJA
Regulation Number
864.7875Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated plasma. The thrombin time test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals.
Device Description
The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated human plasma. The thrombin time test is a one-stage quantitative clotting test performed on citrated plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals. The test may be performed manually, or using semi-automated and automated coagulation analyzers.
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K Number
K970645Device Name
BC THROMBIN REAGENT
Manufacturer
BEHRING DIAGNOSTICS, INC.
Date Cleared
1997-05-19
(88 days)
Product Code
GJA
Regulation Number
864.7875Why did this record match?
Search-Everything :
Matched: '864.7875'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BC Thrombin Reagent is intended for the determination of the thrombin time in human plasma. The determination of thrombin time is important in:
- The monitoring of heparin therapy.
- The monitoring of fibrinolysis therapy.
- The screening of disorders of fibrin formation.
- The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders.
Device Description
The BC Thrombin Reagent consists of lyophilized bovine thrombin and bovine albumin, and buffer solution (HEPES).
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