MIU · Class I · 21 CFR 866.3870

FDA Product Code MIU: Enzyme Linked Immunosorbent Assay, T. Cruzi

Leading manufacturers include Wiener Laboratories Saic, Ortho-Clinical Diagnostics, Inc. and Gull Laboratories, Inc..

6
Total
6
Cleared
490d
Avg days
1992
Since

FDA 510(k) Cleared Enzyme Linked Immunosorbent Assay, T. Cruzi Devices (Product Code MIU)

6 devices
1–6 of 6
Cleared Apr 15, 2009
ORTHO T. CRUZI ELISA TEST SYSTEM
K072732
Ortho-Clinical Diagnostics, Inc.
Microbiology · 567d
Cleared Feb 11, 2004
WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
K023889
Wiener Laboratories Saic
Microbiology · 447d
Cleared May 19, 1995
HEMAGEN CHAGAS' KIT (EIA METHOD)
K930272
Hemagen Diagnostics, Inc.
Microbiology · 850d
Cleared Dec 19, 1994
ABBOTT CHAGAS ANTIBODY EIA
K933716
Abbott Laboratories
Microbiology · 507d
Cleared May 04, 1992
CHAGAS' IGG ELISA TEST
K911233
Gull Laboratories, Inc.
Microbiology · 411d

About Product Code MIU - Regulatory Context