BIOCOACH Blood Ketone Test Strips 50 Pack (Foil)

FDA UDI

Class I (US FDA UDI)

by Amventurex, Inc.

Identity

Trade Name: BIOCOACH Blood Ketone Test Strips 50 Pack (Foil) FDA UDI
Generic Name: Ketone (acetoacetate) IVD, reagent FDA UDI
Device Name: 50s FDA UDI
Model / Reference: S5640934 FDA UDI
Description: 50s FDA UDI

Identifiers

Catalog Number: S5640934 FDA UDI
Primary DI / UDI-DI: 00850017460089 FDA UDI
510(k) Number: K201880 FDA UDI
FDA Product Code: JIN FDA UDI
GMDN Term: Ketone (acetoacetate) IVD, reagent FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1435 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ketone (acetoacetate) IVD, reagent

BIOCOACH Blood Ketone Test Strips 50 Pack (Foil) by Amventurex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ketone (acetoacetate) IVD, reagent.

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keto mojo β-ketone test strips (50pcs/box) — KETO-CHECK, INC. · Class II
KetoBM — Ketobm LLC · Class I
KetoSens — i-SENS, Inc. · Class I
bkt ß-Ketone Test Strips (100 pcs/box) — Adam Lawrence · Class II

Cleared under the same submission

K201880 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Amventurex, Inc.

Sources (1)

FDA UDI 36032f9b-bc14-42f9-bedc-17482faae94e 35 fields · synced May 30, 2026