Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems

FDA UDI

Class I (US FDA UDI)

by Fisher Diagnostics

Identity

Trade Name: Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems FDA UDI
Generic Name: Ammonia IVD, kit, spectrophotometry FDA UDI
Model / Reference: OL60101 FDA UDI

Identifiers

Primary DI / UDI-DI: 00845275005400 FDA UDI
FDA Product Code: JIF FDA UDI
GMDN Term: Ammonia IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1065 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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: Ammonia IVD, kit, spectrophotometry

Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems by Fisher Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Fisher Diagnostics

Sources (1)

FDA UDI a3ee41c4-bee7-41f3-aa48-274035d8434b 34 fields · synced May 30, 2026