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AutoDELFIA Sample Processor

FDA UDI

Class I (US FDA UDI)

by Wallac, Inc.

Identity

Trade Name
AutoDELFIA Sample Processor FDA UDI
Generic Name
Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Device Name
Used with 1235-514 Fully Automatic DELFIA® System FDA UDI
Model / Reference
1297-014 FDA UDI
Description
Used with 1235-514 Fully Automatic DELFIA® System FDA UDI

Identifiers

Catalog Number
1297-014 FDA UDI
Primary DI / UDI-DI
06438147116157 FDA UDI
FDA Product Code
KHO FDA UDI
GMDN Term
Fluorescent immunoassay analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2560 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Fluorescent immunoassay analyser IVD, laboratory

AutoDELFIA Sample Processor by Wallac, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluorescent immunoassay analyser IVD, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wallac, Inc.

Sources (1)

  • FDA UDI ffc68955-fde3-40c9-bd19-e411f54327b9 34 fields · synced May 31, 2026