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Alinity c ACE Assay File

FDA UDI

Class I (US FDA UDI)

by Sentinel Ch. Srl

Identity

Trade Name
Alinity c ACE Assay File FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware. FDA UDI
Model / Reference
06U86-1A FDA UDI
Description
The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware. FDA UDI

Identifiers

Catalog Number
06U86-1A FDA UDI
Primary DI / UDI-DI
08058056685445 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

Yes

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 ACE Assay File by Sentinel Ch. Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
Sentinel Ch. Srl

Sources (1)

  • FDA UDI 7f6ab125-2ab0-4e74-a76b-b8c002423043 35 fields · synced Jun 1, 2026