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Alinity

FDA UDI

Class I (US FDA UDI)

by Abbott

Identity

Trade Name
Alinity FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
Alinity c TPRO2 Assay File FDA UDI
Model / Reference
04T811A FDA UDI
Description
Alinity c TPRO2 Assay File FDA UDI

Identifiers

Catalog Number
04T811A FDA UDI
Primary DI / UDI-DI
00380740186159 FDA UDI
FDA Product Code
JJE FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2160 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory instrument/analyser application software IVD

Alinity c TPRO2 Assay File is a laboratory instrument/analyser application software designed for use with an incubation control, data processing, display, or communication, and produces raw-data-derived qualitative result calculations based on specified criteria. The software does not use demographic or clinical data to produce a patient score.

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI 903a30bf-9753-4743-a659-8968142407c0 35 fields · synced Jul 24, 2026