Product code PJE— Clinical Chemistry
MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
- Classification name
- Blood/Plasma Collection Device For Dna Testing
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Total cleared
- 8
- First cleared
- Most recent
FDA classification 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.”
Market context for product code PJE
FDA has cleared devices under product code PJE between 1998 and 2023, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2015
- 2005
- 2003
- 2002
- 2001
- 1998
Top applicants under product code PJE
Adverse events under product code PJE
product code PJE- Malfunction
- 540
- Total
- 540
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code PJE
- K231469 — PAXgene® Blood DNA Tube
- K142821 — PAXgene Blood DNA Tube
- K042927 — VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
- K031359 — S-MONOVETTE EDTA K2-GEL
- K014104 — VACUETTE EDTA K2 TUBES
- K012043 — VACUETTE EDTA K2 GEL TUBES
- K010328 — MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
- K972075 — VACUTAINER BRAND PPT PLASMA PREPARATION TUBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.