ACE Alera® 402900-1

GUDID 00857969006693

ACE Alera Clinical Chemistry System with ISE

ALFA WASSERMANN, INC.

Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
Primary Device ID00857969006693
NIH Device Record Key8ba14d9a-efa8-4d1a-b81a-0f3a56f88149
Commercial Distribution StatusIn Commercial Distribution
Brand NameACE Alera®
Version Model Number402900-1
Catalog Number402900-1
Company DUNS781990924
Company NameALFA WASSERMANN, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com
Phone973-852-0178
EmailAGennis@alfawassermannus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857969006693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-15
Device Publish Date2021-01-07

Devices Manufactured by ALFA WASSERMANN, INC.

00857969006693 - ACE Alera®2021-01-15ACE Alera Clinical Chemistry System with ISE
00857969006693 - ACE Alera®2021-01-15 ACE Alera Clinical Chemistry System with ISE
00857969006709 - ACE Axcel®2021-01-15 ACE Axcel Clinical Chemistry System with ISE
00857969006662 - ACE2020-07-09 ALT Reagent
00857969006679 - ACE2020-07-09 AST Reagent
00857969006686 - ACE2020-07-09 AST Reagent
00857969006624 - ACE2020-04-17 NORMAL SALINE DILUENT
00857969006631 - ACE2020-04-17 SYSTEM DILUENT
00857969006648 - ACE2020-04-17 ISE WASH

Trademark Results [ACE Alera]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACE ALERA
ACE ALERA
78345133 3016230 Live/Registered
Alfa Wassermann, Inc.
2003-12-23
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