Thermo Scientific Infinity™

FDA UDI

Class II (US FDA UDI)

by Fisher Diagnostics

Identity

Trade Name: Thermo Scientific Infinity™ FDA UDI
Generic Name: Urea IVD, kit, enzyme spectrophotometry FDA UDI
Model / Reference: TR12421 FDA UDI

Identifiers

Primary DI / UDI-DI: 00845275000351 FDA UDI
510(k) Number: K973869 FDA UDI
FDA Product Code: CDQ FDA UDI
GMDN Term: Urea IVD, kit, enzyme spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1770 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: Urea IVD, kit, enzyme spectrophotometry

Thermo Scientific Infinity™ by Fisher Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K973869 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: Fisher Diagnostics

Sources (1)

FDA UDI 522430c5-23db-4f37-8274-21c6d5e0a92a 35 fields · synced May 30, 2026