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BIOCOACH Blood Glucose and Ketone Monitoring System

FDA UDI

Class I (US FDA UDI)

by Amventurex, Inc.

Identity

Trade Name
BIOCOACH Blood Glucose and Ketone Monitoring System FDA UDI
Generic Name
Ketone (acetoacetate) IVD, kit, spectrophotometry FDA UDI
Device Name
Complete Kit FDA UDI
Model / Reference
S84102 FDA UDI
Description
Complete Kit FDA UDI

Identifiers

Catalog Number
S84102 FDA UDI
Primary DI / UDI-DI
00850017460034 FDA UDI
510(k) Number
K201880 FDA UDI
FDA Product Code
JIN FDA UDI
NBW FDA UDI
GMDN Term
Ketone (acetoacetate) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1435 FDA UDI
862.1345 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose monitoring system IVD, home-useKetone (acetoacetate) IVD, kit, spectrophotometry

BIOCOACH Blood Glucose and Ketone Monitoring System by Amventurex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ketone (acetoacetate) IVD, kit, spectrophotometry.

Cleared under the same submission

K201880 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amventurex, Inc.

Sources (1)

  • FDA UDI 4ee87e06-8a99-4b33-a931-c4ce5e401707 35 fields · synced Jun 8, 2026