Control, Plasma, Abnormal

Device Code: 2251

Product Code(s): GGC

Device Classification Information

Device Type ID	2251
Device Name	Control, Plasma, Abnormal
Regulation Description	Multipurpose System For In Vitro Coagulation Studies.
Regulation Medical Specialty	Hematology
Review Panel	Hematology
Premarket Review	Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type	510(K) Exempt
CFR Regulation Number	864.5425 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	GGC
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

7-101 CLSI H51-A Assays Of VonWillebrand Factor Antigen And Ristocetin Cofactor Activity; Approved Guideline. 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	2251
Device	Control, Plasma, Abnormal
Product Code	GGC
FDA Device Classification	Class 2 Medical Device
Regulation Description	Multipurpose System For In Vitro Coagulation Studies.
CFR Regulation Number	864.5425 [🔎]

TPLC Last Update: 2019-04-02 20:08:24