Alinity

FDA UDI

Class I (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: Alinity FDA UDI
Generic Name: Chemiluminescent immunoassay analyser IVD FDA UDI
Device Name: Alinity Reagent Replacement Caps FDA UDI
Model / Reference: 04R4701 FDA UDI
Description: Alinity Reagent Replacement Caps FDA UDI

Identifiers

Catalog Number: 04R4701 FDA UDI
Primary DI / UDI-DI: 00380740132705 FDA UDI
FDA Product Code: JJE FDA UDI
MZA FDA UDI
GMDN Term: Chemiluminescent immunoassay analyser 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple clinical chemistry analyser IVD, laboratory Chemiluminescent immunoassay analyser IVD

Alinity by Abbott Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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VITROS — Ortho-Clinical Diagnostics · Class I
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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: Abbott Laboratories, Inc.

Sources (1)

FDA UDI ca2c91e2-9160-4562-9d6c-5549ccd4a384 36 fields · synced May 31, 2026