Product code MQA— Immunology

FDA has cleared 4 devices under product code MQA between 1996 and 2021, filed by 4 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.

• 20211 clearance
• 20031 clearance
• 19981 clearance
• 19961 clearance

• Theratest Laboratories, Inc.1 clearance
• Phadia AB1 clearance
• Inova Diagnostics, Inc.1 clearance
• Hogan & Hartson1 clearance

• K202540 — EliA Rib-PPhadia AB·2021-09-13
• K024151 — EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN PTheratest Laboratories, Inc.·2003-02-06
• K981237 — QUANTA LITE RIBOSOME P ELISAInova Diagnostics, Inc.·1998-06-05
• K950169 — RIBOSOMAL P EIA TEST SYSTEMHogan & Hartson·1996-05-23