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Thermo Scientific Infinity™

FDA UDI

Class II (US FDA UDI)

by Fisher Diagnostics

Identity

Trade Name
Thermo Scientific Infinity™ FDA UDI
Generic Name
Lithium therapeutic drug monitoring IVD, calibrator FDA UDI
Model / Reference
TR66901 FDA UDI

Identifiers

Primary DI / UDI-DI
00845275000429 FDA UDI
510(k) Number
K003583 FDA UDI
FDA Product Code
NDW FDA UDI
GMDN Term
Lithium therapeutic drug monitoring IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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: Lithium therapeutic drug monitoring IVD, calibrator

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

Similar devices

Also classified as Lithium therapeutic drug monitoring IVD, calibrator.

Cleared under the same submission

K003583 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fisher Diagnostics

Sources (1)

  • FDA UDI 00a03948-9a3b-4d1a-8319-e3db75870d86 35 fields · synced Jun 8, 2026