Rightest

FDA UDI

Class II (US FDA UDI)

by Bionime Corporation

Identity

Trade Name: RIGHTEST FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: 1 meter - 00883489001986 1 lancing device - 00883489002013 1 control solution -00883489002020 FDA UDI
Model / Reference: GM700SB FDA UDI
Description: 1 meter - 00883489001986 1 lancing device - 00883489002013 1 control solution -00883489002020 FDA UDI

Identifiers

Primary DI / UDI-DI: 00883489001993 FDA UDI
510(k) Number: K190564 FDA UDI
FDA Product Code: NBW FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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-use

Rightest by Bionime Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glucose monitoring system IVD, home-use.

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ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC. · Class II
LEADER — Cardinal Health 110, Inc. · Class II
CareSens N Voice Multi — i-SENS, Inc. · Class II

Cleared under the same submission

K190564 also covers:

RIGHTEST — Bionime Corporation

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 II	Pending data

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Manufacturer

Manufacturer: Bionime Corporation

Sources (1)

FDA UDI d0f10a37-5c9c-44c1-b7fa-1f7ed5db6a77 34 fields · synced May 31, 2026