Product code MJA— Microbiology

FDA has cleared 5 devices under product code MJA between 1999 and 2006, filed by 3 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.

• 20061 clearance
• 20022 clearances
• 20011 clearance
• 19991 clearance

• Trek Diagnostic Systems, Inc.2 clearances
• Becton, Dickinson & CO2 clearances
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

Malfunction

827

Total

827

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K052323 — VERSATREK MYCO PZA KITTrek Diagnostic Systems, Inc.·2006-01-19
• K021582 — BACTEC MGIT 960 PZA KITBecton, Dickinson & CO·2002-07-13
• K014123 — BACTEC MGIT 960 SIRE KITSBecton, Dickinson & CO·2002-04-19
• K003062 — BACTEC MGIT 960 SIR KITSBd Becton Dickinson Vacutainer Systems Preanalytic·2001-06-06
• K972772 — ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTINGTrek Diagnostic Systems, Inc.·1999-07-13