FDA.reportPublic FDA data

ACE Axcel®

Primary DI
00857969006709
Brand
ACE Axcel®
Company
ALFA WASSERMANN, INC.
Model
404200-1
Catalog number
404200-1
Device description
ACE Axcel Clinical Chemistry System with ISE
Published
2021-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113253000ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2012-05-17JJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857969006709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857969006709008579690067098579690067090857969006709

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel clinical chemistry analyser IVD, point-of-care, line-poweredA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, metabolites, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents and incorporates multiple channels using more two or more technologies which may include microfluidics, enzymatic chemistry, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
973-852-0178AGennis@alfawassermannus.com

Regulatory Flags#

DUNS number
781990924
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857969006136ACESA2001SA20012016-09-24
00857969006068ACERX1012RX10122016-09-24
00857969006112ACESA1012SA10122016-09-24
00857969006433Alfa WassermannC2-87C2-872017-10-10
00857969006693ACE Alera®402900-1402900-12021-01-07
00857969006181Alfa WassermannS1-33S1-332016-09-24
00857969006198Alfa WassermannS2-85S2-852016-09-24
00857969006396Alfa WassermannC1-42017-07-25
00857969006402Alfa WassermannC1-5C1-52017-07-25
00857969006662ACESA1052SA10522020-07-01
00857969006679ACESA1053SA10532020-07-01
00857969006686ACERX1053RX10532020-07-01
00857969006624ACESA1020SA10202020-04-09
00857969006631ACESA1021SA10212020-04-09
00857969006648ACESA1027SA10272020-04-09
00857969006655ACESA1028SA10282020-04-09
00857969006600Alfa WassermannS2-87S2-872020-04-03
00857969006617ACESA1050SA10502020-04-03
00857969006020ACEACI-32ACI-322017-10-10
00857969006419ACEC2-85C2-852017-10-10

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Primary DI, Brand, Company table
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00816879025057NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879027372NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
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