FDA Product Code PJE: Blood/plasma Collection Device For Dna Testing
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.
Leading manufacturers include Greiner Vacuette North America, Inc., Preanalytix GmbH and Izon Business Products, Inc..
8
Total
8
Cleared
144d
Avg days
1998
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Blood/plasma Collection Device For Dna Testing Devices (Product Code PJE)
8 devices
Cleared
Jun 21, 2023
PAXgene® Blood DNA Tube
Preanalytix GmbH
Chemistry
30d
Cleared
Sep 09, 2015
PAXgene Blood DNA Tube
Preanalytix GmbH
Toxicology
344d
Cleared
Apr 15, 2005
VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
Greiner Bio-One Vacuette North America
Chemistry
175d
Cleared
Sep 12, 2003
S-MONOVETTE EDTA K2-GEL
Sarstedt, Inc.
Chemistry
135d
Cleared
Feb 01, 2002
VACUETTE EDTA K2 TUBES
Greiner Vacuette North America, Inc.
Chemistry
50d
Cleared
Sep 24, 2001
VACUETTE EDTA K2 GEL TUBES
Greiner Vacuette North America, Inc.
Chemistry
87d
Cleared
Apr 09, 2001
MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
Izon Business Products, Inc.
Chemistry
66d
Cleared
Feb 24, 1998
VACUTAINER BRAND PPT PLASMA PREPARATION TUBE
Becton Dickinson Vacutainer Systems
Chemistry
266d
About Product Code PJE - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PJE since 1998, with 8 receiving FDA clearance (average review time: 144 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.