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

Antisera, Neutralization, Echovirus 1-34

21 CFR 866.3205 / Microbiology
FDA source (opens on fda.gov)

GNI is the FDA product code for Antisera, Neutralization, Echovirus 1-34, a class I device type, regulated under 21 CFR 866.3205. As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
GNI
Device name
Antisera, Neutralization, Echovirus 1-34
Regulation
21 CFR 866.3205
Device class
Class I
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
0

Companies listing this code with FDA

Companies whose registered establishments list this code