Product code MIU— Microbiology

FDA has cleared 6 devices under product code MIU between 1992 and 2016, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20161 clearance
• 20091 clearance
• 20041 clearance
• 19951 clearance
• 19941 clearance
• 19921 clearance

• Wiener Laboratories Saic1 clearance
• Ortho-Clinical Diagnostics, Inc.1 clearance
• InBios International, Inc.1 clearance
• Hemagen Diagnostics, Inc.1 clearance
• Gull Laboratories, Inc.1 clearance
• Abbott Laboratories1 clearance

• K161947 — Chagas Detect Plus Rapid TestInBios International, Inc.·2016-12-16
• K072732 — ORTHO T. CRUZI ELISA TEST SYSTEMOrtho-Clinical Diagnostics, Inc.·2009-04-15
• K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254Wiener Laboratories Saic·2004-02-11
• K930272 — HEMAGEN CHAGAS' KIT (EIA METHOD)Hemagen Diagnostics, Inc.·1995-05-19
• K933716 — ABBOTT CHAGAS ANTIBODY EIAAbbott Laboratories·1994-12-19
• K911233 — CHAGAS' IGG ELISA TESTGull Laboratories, Inc.·1992-05-04