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PJE — Blood/Plasma Collection Device For Dna Testing Class II

FDA Device Classification

Classification Details

Product Code
PJE
Device Class
Class II
Regulation Number
862.1675
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Definition

A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231469preanalytixPAXgene® Blood DNA TubeJune 21, 2023
K142821preanalytixPAXgene Blood DNA TubeSeptember 9, 2015
K042927greiner bio-one vacuette north americaVACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBESApril 15, 2005
K031359sarstedtS-MONOVETTE EDTA K2-GELSeptember 12, 2003
K014104greiner vacuette north americaVACUETTE EDTA K2 TUBESFebruary 1, 2002
K012043greiner vacuette north americaVACUETTE EDTA K2 GEL TUBESSeptember 24, 2001
K010328izon business productsMULTIPLE (IZON DNA BLOOD COLLECTION KIT)April 9, 2001
K972075becton dickinson vacutainer systemsVACUTAINER BRAND PPT PLASMA PREPARATION TUBEFebruary 24, 1998