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

Reagents, Specific, Analyte

21 CFR 864.4020 / Pathology
FDA source (opens on fda.gov)

MVU is the FDA product code for Reagents, Specific, Analyte, a class I device type, regulated under 21 CFR 864.4020. As of , FDA records hold no 510(k) clearances under this code and 43 recalls.

Classification record

Product code
MVU
Device name
Reagents, Specific, Analyte
Regulation
21 CFR 864.4020
Device class
Class I
Review panel
Pathology
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
43

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 109 companies shown, in name order