510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PJEClass II

Blood/Plasma Collection Device For Dna Testing

21 CFR 862.1675 / Clinical Chemistry
FDA source (opens on fda.gov)

PJE is the FDA product code for Blood/Plasma Collection Device For Dna Testing, a class II device type, regulated under 21 CFR 862.1675. FDA's definition for this code reads: "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". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PJE
Device name
Blood/Plasma Collection Device For Dna Testing
FDA 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.
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code PJE

By decision year
8 clearances under product code PJE with a decision year between 1998 and 2023, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PJE by decision year
YearClearances
19981
20012
20021
20031
20051
20151
20231

Applicants with the most clearances

Product code PJE
Applicants holding the most 510(k) clearances under product code PJE
ApplicantClearances
Greiner Bio-One North America, Inc.2
Preanalytix GmbH2
Becton Dickinson Vacutainer Systems1
Greiner Bio-One Vacuette North America1
Izon Business Products, Inc.1
Sarstedt ApS1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order