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LIR — Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae Class II

FDA Device Classification

FDA product code LIR covers "Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae", a Class II medical device regulated under 21 CFR 866.3390. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LIR
Device Class
Class II
Regulation Number
866.3390
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K023947thermo biostarGC OIAApril 17, 2003
K882534abbott laboratoriesABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROLJuly 12, 1988
K881064hygeia sciencesHYGEIA GC TESTJune 2, 1988

FDA data resources