510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PITClass I

Leishmania Spp. Antigen Detection Assay

21 CFR 866.3870 / Microbiology
FDA source (opens on fda.gov)

PIT is the FDA product code for Leishmania Spp. Antigen Detection Assay, a class I device type, regulated under 21 CFR 866.3870. FDA's definition for this code reads: "An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PIT
Device name
Leishmania Spp. Antigen Detection Assay
FDA definition
An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.
Regulation
21 CFR 866.3870
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code PIT

By decision year
1 clearance under product code PIT with a decision year between 2014 and 2014, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PIT by decision year
YearClearances
20141

Applicants with the most clearances

Product code PIT
Applicants holding the most 510(k) clearances under product code PIT
ApplicantClearances
Inbios International, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code