Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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036
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Date of Entry 07/09/2014
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FR Recognition Number
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7-213
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Standard | |
CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition |
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Scope/AbstractThis standard considers multiple variables that are involved in handling and processing blood specimens. Its application should enable the user to recognize and control accuracy and precision factors that occur between the time of blood collection and the time of test performance. |
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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 |
§864.3250 |
Container, Specimen Mailer And Storage, Sterile |
Class 1 |
KDT |
§864.3250 |
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile |
Class 1 |
KDW |
§864.3250 |
Container, Specimen, Sterile |
Class 1 |
FMH |
§862.1675 |
Tray, Blood Collection |
Class 2 |
GJE |
§862.1675 |
Tubes, Vacuum Sample, With Anticoagulant |
Class 2 |
GIM |
§862.1675 |
Tubes, Vials, Systems, Serum Separators, Blood Collection |
Class 2 |
JKA |
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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. |