Antithrombin Iii Quantitation

Device Code: 2339

Product Code(s): JBQ

Device Classification Information

Device Type ID	2339
Device Name	Antithrombin Iii Quantitation
Regulation Description	Antithrombin III Assay.
Regulation Medical Specialty	Hematology
Review Panel	Hematology
Premarket Review	Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type	510(k)
CFR Regulation Number	864.7060 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	JBQ
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

7-159 CLSI H21-A5 Collection, Transport, And Processing Of Blood Specimens For Testing Plasma-Based Coagulation Assays And Molecular Hemostasis Assays

Total Product Life Cycle

Device Type ID	2339
Device	Antithrombin Iii Quantitation
Product Code	JBQ
FDA Device Classification	Class 2 Medical Device
Regulation Description	Antithrombin III Assay.
CFR Regulation Number	864.7060 [🔎]

TPLC Last Update: 2019-04-02 20:10:04