Synermed®

FDA UDI

Class I (US FDA UDI)

by Infrared Laboratory Systems Llc

Identity

Trade Name: Synermed® FDA UDI
Generic Name: Inorganic phosphate (PO43-) IVD, reagent FDA UDI
Device Name: Phosphorus Reagent 4 X 50 mL + 2 X 40 mL FDA UDI
Model / Reference: IR110-911 FDA UDI
Description: Phosphorus Reagent 4 X 50 mL + 2 X 40 mL FDA UDI

Identifiers

Catalog Number: IR110-911 FDA UDI
Primary DI / UDI-DI: 05060500091248 FDA UDI
510(k) Number: K912569 FDA UDI
FDA Product Code: CEO FDA UDI
GMDN Term: Inorganic phosphate (PO43-) IVD, reagent FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1580 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: Inorganic phosphate (PO43-) IVD, reagent

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

Similar devices

Also classified as Inorganic phosphate (PO43-) IVD, reagent.

BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Phosphorus UV, 2 x 100 mL — Chronolab Systems, S.L. · IVD General
Liquick Cor-PHOSPHORUS 30 — PZ CORMAY Spółka Akcyjna · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Pointe Scientific, Inc. Phosphorus — POINTE SCIENTIFIC, INC. · Class I
ACCENT-300 PHOSPHORUS — PZ CORMAY Spółka Akcyjna · IVD General
Alinity — Abbott · Class I
Fosforo UV — GIESSE DIAGNOSTICS SRL · IVD General

Cleared under the same submission

K912569 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: Infrared Laboratory Systems Llc

Sources (1)

FDA UDI bd724f2d-05a2-4a80-80e2-be6ee367f50f 37 fields · synced May 31, 2026