LSIClass II

Antiserum, Blastomyces Dermatitidis, Other

21 CFR 866.3060 / Microbiology

LSI is the FDA product code for Antiserum, Blastomyces Dermatitidis, Other, a class II device type, regulated under 21 CFR 866.3060. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: LSI
Device name: Antiserum, Blastomyces Dermatitidis, Other
Regulation: 21 CFR 866.3060
Device class: Class II
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

IMMY, Inc.

Recent clearances

Product code LSI

FDA records hold no clearances under product code LSI.

Recent recalls

Product code LSI

Z-0606-2018Class IIThe firm information that the product was reporting false positive resultsGibson Laboratories LLC / initiated 2017-01-20 / 10/1 mL vials

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)