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

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

21 CFR 866.3780 / Microbiology
FDA source (opens on fda.gov)

LGD is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, a class II device type, regulated under 21 CFR 866.3780. As of , FDA records hold 106 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LGD
Device name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
106
Ingested recalls
7

Clearances, product code LGD

By decision year
106 clearances under product code LGD with a decision year between 1982 and 2025, 1988 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code LGD by decision year
YearClearances
19821
19844
19852
19867
19876
19889
19899
19907
19914
19928
19933
19953
19968
19976
19982
19992
20003
20013
20023
20032
20061
20082
20091
20112
20132
20151
20171
20221
20242
20251

Applicants with the most clearances

Product code LGD
Applicants holding the most 510(k) clearances under product code LGD
ApplicantClearances
Abbott Medical12
Siemens Healthcare Diagnostics Inc.12
Gull Laboratories, Inc.6
Labsystems, Inc.5
Diamedix Corp.4
bioMerieux, Inc.4
Zeus Scientific LLC4
Biomerieux Vitek, Inc.3
Diasorin Inc.3
Incstar Corp.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order