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

Breast Milk-Alcohol Test System

21 CFR 862.3040 / Clinical Toxicology
FDA source (opens on fda.gov)

ORA is the FDA product code for Breast Milk-Alcohol Test System, a class II device type, regulated under 21 CFR 862.3040. FDA's definition for this code reads: "Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
ORA
Device name
Breast Milk-Alcohol Test System
FDA definition
Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk.
Regulation
21 CFR 862.3040
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
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

No registered establishment in MDM’s records lists product code ORA.