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ACE Axcel®

FDA UDI

Class I (US FDA UDI)

by Alfa Wassermann, Inc.

Identity

Trade Name
ACE Axcel® FDA UDI
Generic Name
Multichannel clinical chemistry analyser IVD, point-of-care, line-powered FDA UDI
Device Name
ACE Axcel Clinical Chemistry System with ISE FDA UDI
Model / Reference
404200-1 FDA UDI
Description
ACE Axcel Clinical Chemistry System with ISE FDA UDI

Identifiers

Catalog Number
404200-1 FDA UDI
Primary DI / UDI-DI
00857969006709 FDA UDI
510(k) Number
K113253 FDA UDI
FDA Product Code
JJE FDA UDI
GMDN Term
Multichannel clinical chemistry analyser IVD, point-of-care, line-powered 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multichannel clinical chemistry analyser IVD, point-of-care, line-powered

ACE Axcel® by Alfa Wassermann, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multichannel clinical chemistry analyser IVD, point-of-care, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alfa Wassermann, Inc.

Sources (1)

  • FDA UDI 47e0b5a8-b370-4375-901e-ee0c6c983abb 36 fields · synced May 30, 2026