PIT · Class I · 21 CFR 866.3870

FDA Product Code PIT: Leishmania Spp. Antigen Detection Assay

An In Vitro Diagnostic Test For The Detection Of Leishmania Spp. Antigens To Aid In The Diagnosis Of Leishmania Spp. Infection.

Leading manufacturers include InBios International, Inc..

1
Total
1
Cleared
177d
Avg days
2014
Since

FDA 510(k) Cleared Leishmania Spp. Antigen Detection Assay Devices (Product Code PIT)

1 devices
1–1 of 1
Cleared Nov 14, 2014
CL DETECT RAPID TEST
K141341
InBios International, Inc.
Microbiology · 177d

About Product Code PIT - Regulatory Context