Synermed®

FDA UDI

Class II (US FDA UDI)

by Infrared Laboratory Systems Llc

Identity

Trade Name: Synermed® FDA UDI
Generic Name: Glucose IVD, reagent FDA UDI
Device Name: Glucose Reagent 6 X 50 mL + 3 X 40 mL FDA UDI
Model / Reference: IR070-911 FDA UDI
Description: Glucose Reagent 6 X 50 mL + 3 X 40 mL FDA UDI

Identifiers

Catalog Number: IR070-911 FDA UDI
Primary DI / UDI-DI: 05060500090951 FDA UDI
510(k) Number: K903063 FDA UDI
FDA Product Code: CGA FDA UDI
GMDN Term: Glucose IVD, reagent 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Glucose IVD, reagent

Synermed® by Infrared Laboratory Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Glucose Tolerance Beverage — AZER SCIENTIFIC INCORPORATED · Class II
Piccolo Basic Metabolic Panel — ABAXIS, INC. · Class II
Vive Precision — VIVE HEALTH LLC · Class II
GoChek2 — Microtech Medical (Hangzhou) Co., Ltd. · Class II

Cleared under the same submission

K903063 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 II	Pending data

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Manufacturer

Manufacturer: Infrared Laboratory Systems Llc

Sources (1)

FDA UDI 38fa91be-9a43-4ae1-bdcb-ca15fc22fcd8 37 fields · synced Jun 8, 2026