Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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020
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Date of Entry 09/09/2008
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FR Recognition Number
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7-159
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Standard | |
CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays |
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Scope/AbstractThis document contains procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and provides general recommendations for performing the tests. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§864.5400 |
Fibrometer |
Class 2 |
GIE |
§864.7060 |
Antigen, Antiserum, Control, Antithrombin Iii |
Class 2 |
DDQ |
§864.7060 |
Antithrombin Iii Quantitation |
Class 2 |
JBQ |
§864.7060 |
Antithrombin Iii, Two Stage Clotting Time Assay |
Class 2 |
JPE |
§864.5425 |
Control, Plasma, Abnormal |
Class 2 |
GGC |
§864.5425 |
Plasma, Coagulation Control |
Class 2 |
GGN |
§864.5425 |
Plasma, Control, Normal |
Class 2 |
GIZ |
§864.5425 |
System, Multipurpose For In Vitro Coagulation Studies |
Class 2 |
JPA |
§864.5680 |
Analyzer, Heparin, Automated |
Class 2 |
JOX |
§864.7290 |
Plasma, Coagulation Factor Deficient |
Class 2 |
GJT |
§864.7290 |
Test, Qualitative And Quantitative Factor Deficiency |
Class 2 |
GGP |
§864.7320 |
Fibrin Split Products |
Class 2 |
GHH |
§864.7320 |
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
Class 2 |
DAP |
§864.7525 |
Assay, Heparin |
Class 2 |
KFF |
§864.7525 |
Protamine Sulphate |
Class 2 |
GFT |
§864.7525 |
Test, Heparin Neutralization |
Class 2 |
JBR |
§864.7750 |
Test, Time, Prothrombin |
Class 2 |
GJS |
§864.7875 |
Test, Thrombin Time |
Class 2 |
GJA |
§864.7875 |
Thrombin |
Class 2 |
GJB |
§864.7925 |
Activated Partial Thromboplastin |
Class 2 |
GFO |
§864.7925 |
Reagent & Control, Partial Thromboplastin Time |
Class 2 |
GIT |
§864.7925 |
Reagent, Thromboplastin And Control |
Class 2 |
GGO |
§864.7925 |
Test, Time, Partial Thromboplastin |
Class 2 |
GGW |
§864.8950 |
Reagent, Russel Viper Venom |
Class 1 |
GIR |
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Relevant FDA Guidance and/or Supportive Publications*
CLSI EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline Third Edition.
CLSI GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard Sixth Edition.
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |
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