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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
Unsaturated iron binding capacity (UIBC) IVD, reagent FDA UDI
Device Name
UIBC Reagent 2 X 66 mL + 2 X 1 mL + 1 X 44 mL FDA UDI
Model / Reference
IR150-1200 FDA UDI
Description
UIBC Reagent 2 X 66 mL + 2 X 1 mL + 1 X 44 mL FDA UDI

Identifiers

Catalog Number
IR150-1200 FDA UDI
Primary DI / UDI-DI
05060500091965 FDA UDI
510(k) Number
K922784 FDA UDI
FDA Product Code
JMO FDA UDI
GMDN Term
Unsaturated iron binding capacity (UIBC) IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1415 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: Unsaturated iron binding capacity (UIBC) 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 Unsaturated iron binding capacity (UIBC) IVD, reagent.

Cleared under the same submission

K922784 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 07590639-75ed-4d7a-96fd-1fdf5270d7f4 37 fields · synced Jun 1, 2026