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Synermed®

FDA UDI

Class I (US FDA UDI)

by Infrared Laboratory Systems Llc

Identity

Trade Name
Synermed® FDA UDI
Generic Name
Glucose/ketone/lipid profile IVD, reagent FDA UDI
Device Name
Triglycerides Reagent 8 X 50 mL (reconstituted) FDA UDI
Model / Reference
IR140-911 FDA UDI
Description
Triglycerides Reagent 8 X 50 mL (reconstituted) FDA UDI

Identifiers

Catalog Number
IR140-911 FDA UDI
Primary DI / UDI-DI
05060500091415 FDA UDI
510(k) Number
K903016 FDA UDI
FDA Product Code
CDT FDA UDI
GMDN Term
Glucose/ketone/lipid profile IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1705 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Glucose/ketone/lipid profile 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 Glucose/ketone/lipid profile IVD, reagent.

Cleared under the same submission

K903016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Infrared Laboratory Systems Llc

Sources (1)

  • FDA UDI 89740551-582e-4bf4-8384-b4488b90a041 37 fields · synced Jun 8, 2026